A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis
Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Gupta, AK [verfasserIn] Leonardi, C [verfasserIn] Stoltz, RR [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|
| Erschienen: |
Oxford, UK: Blackwell Science Ltd ; 2005 |
|---|
| Schlagwörter: |
|---|
| Umfang: |
Online-Ressource |
|---|
| Reproduktion: |
2005 ; Blackwell Publishing Journal Backfiles 1879-2005 |
|---|---|
| Übergeordnetes Werk: |
In: Journal of the European Academy of Dermatology and Venereology - European Academy of Dermatology and Venereology ; GKD-ID: 30105705, Oxford [u.a.] : Wiley-Blackwell, 1991, 19(2005), 4, Seite 0 |
| Übergeordnetes Werk: |
volume:19 ; year:2005 ; number:4 ; pages:0 |
| Links: |
|---|
| DOI / URN: |
10.1111/j.1468-3083.2005.01212.x |
|---|
| Katalog-ID: |
NLEJ243291884 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLEJ243291884 | ||
| 003 | DE-627 | ||
| 005 | 20230506104043.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 120427s2005 xx |||||o 00| ||und c | ||
| 024 | 7 | |a 10.1111/j.1468-3083.2005.01212.x |2 doi | |
| 035 | |a (DE-627)NLEJ243291884 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 100 | 1 | |a Gupta, AK |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| 264 | 1 | |a Oxford, UK |b Blackwell Science Ltd |c 2005 | |
| 300 | |a Online-Ressource | ||
| 336 | |a nicht spezifiziert |b zzz |2 rdacontent | ||
| 337 | |a nicht spezifiziert |b z |2 rdamedia | ||
| 338 | |a nicht spezifiziert |b zu |2 rdacarrier | ||
| 520 | |a Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. | ||
| 533 | |d 2005 |f Blackwell Publishing Journal Backfiles 1879-2005 |7 |2005|||||||||| | ||
| 650 | 4 | |a onychomycosis | |
| 700 | 1 | |a Leonardi, C |e verfasserin |4 aut | |
| 700 | 1 | |a Stoltz, RR |e verfasserin |4 aut | |
| 700 | 1 | |a Pierce, PF |4 oth | |
| 700 | 1 | |a Conetta, B |4 oth | |
| 773 | 0 | 8 | |i In |a European Academy of Dermatology and Venereology ; GKD-ID: 30105705 |t Journal of the European Academy of Dermatology and Venereology |d Oxford [u.a.] : Wiley-Blackwell, 1991 |g 19(2005), 4, Seite 0 |h Online-Ressource |w (DE-627)NLEJ243926189 |w (DE-600)2022088-1 |x 1468-3083 |7 nnns |
| 773 | 1 | 8 | |g volume:19 |g year:2005 |g number:4 |g pages:0 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x |q text/html |x Verlag |z Deutschlandweit zugänglich |3 Volltext |
| 912 | |a GBV_USEFLAG_U | ||
| 912 | |a ZDB-1-DJB | ||
| 912 | |a GBV_NL_ARTICLE | ||
| 951 | |a AR | ||
| 952 | |d 19 |j 2005 |e 4 |h 0 | ||
| author_variant |
a g ag c l cl r s rs |
|---|---|
| matchkey_str |
article:14683083:2005----::paeirnoiedulbidlcbcnrledsrnigtdeautntefiayaeynpamckntcorv |
| hierarchy_sort_str |
2005 |
| publishDate |
2005 |
| allfields |
10.1111/j.1468-3083.2005.01212.x doi (DE-627)NLEJ243291884 DE-627 ger DE-627 rakwb Gupta, AK verfasserin aut A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis Oxford, UK Blackwell Science Ltd 2005 Online-Ressource nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. 2005 Blackwell Publishing Journal Backfiles 1879-2005 |2005|||||||||| onychomycosis Leonardi, C verfasserin aut Stoltz, RR verfasserin aut Pierce, PF oth Conetta, B oth In European Academy of Dermatology and Venereology ; GKD-ID: 30105705 Journal of the European Academy of Dermatology and Venereology Oxford [u.a.] : Wiley-Blackwell, 1991 19(2005), 4, Seite 0 Online-Ressource (DE-627)NLEJ243926189 (DE-600)2022088-1 1468-3083 nnns volume:19 year:2005 number:4 pages:0 http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x text/html Verlag Deutschlandweit zugänglich Volltext GBV_USEFLAG_U ZDB-1-DJB GBV_NL_ARTICLE AR 19 2005 4 0 |
| spelling |
10.1111/j.1468-3083.2005.01212.x doi (DE-627)NLEJ243291884 DE-627 ger DE-627 rakwb Gupta, AK verfasserin aut A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis Oxford, UK Blackwell Science Ltd 2005 Online-Ressource nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. 2005 Blackwell Publishing Journal Backfiles 1879-2005 |2005|||||||||| onychomycosis Leonardi, C verfasserin aut Stoltz, RR verfasserin aut Pierce, PF oth Conetta, B oth In European Academy of Dermatology and Venereology ; GKD-ID: 30105705 Journal of the European Academy of Dermatology and Venereology Oxford [u.a.] : Wiley-Blackwell, 1991 19(2005), 4, Seite 0 Online-Ressource (DE-627)NLEJ243926189 (DE-600)2022088-1 1468-3083 nnns volume:19 year:2005 number:4 pages:0 http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x text/html Verlag Deutschlandweit zugänglich Volltext GBV_USEFLAG_U ZDB-1-DJB GBV_NL_ARTICLE AR 19 2005 4 0 |
| allfields_unstemmed |
10.1111/j.1468-3083.2005.01212.x doi (DE-627)NLEJ243291884 DE-627 ger DE-627 rakwb Gupta, AK verfasserin aut A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis Oxford, UK Blackwell Science Ltd 2005 Online-Ressource nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. 2005 Blackwell Publishing Journal Backfiles 1879-2005 |2005|||||||||| onychomycosis Leonardi, C verfasserin aut Stoltz, RR verfasserin aut Pierce, PF oth Conetta, B oth In European Academy of Dermatology and Venereology ; GKD-ID: 30105705 Journal of the European Academy of Dermatology and Venereology Oxford [u.a.] : Wiley-Blackwell, 1991 19(2005), 4, Seite 0 Online-Ressource (DE-627)NLEJ243926189 (DE-600)2022088-1 1468-3083 nnns volume:19 year:2005 number:4 pages:0 http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x text/html Verlag Deutschlandweit zugänglich Volltext GBV_USEFLAG_U ZDB-1-DJB GBV_NL_ARTICLE AR 19 2005 4 0 |
| allfieldsGer |
10.1111/j.1468-3083.2005.01212.x doi (DE-627)NLEJ243291884 DE-627 ger DE-627 rakwb Gupta, AK verfasserin aut A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis Oxford, UK Blackwell Science Ltd 2005 Online-Ressource nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. 2005 Blackwell Publishing Journal Backfiles 1879-2005 |2005|||||||||| onychomycosis Leonardi, C verfasserin aut Stoltz, RR verfasserin aut Pierce, PF oth Conetta, B oth In European Academy of Dermatology and Venereology ; GKD-ID: 30105705 Journal of the European Academy of Dermatology and Venereology Oxford [u.a.] : Wiley-Blackwell, 1991 19(2005), 4, Seite 0 Online-Ressource (DE-627)NLEJ243926189 (DE-600)2022088-1 1468-3083 nnns volume:19 year:2005 number:4 pages:0 http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x text/html Verlag Deutschlandweit zugänglich Volltext GBV_USEFLAG_U ZDB-1-DJB GBV_NL_ARTICLE AR 19 2005 4 0 |
| allfieldsSound |
10.1111/j.1468-3083.2005.01212.x doi (DE-627)NLEJ243291884 DE-627 ger DE-627 rakwb Gupta, AK verfasserin aut A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis Oxford, UK Blackwell Science Ltd 2005 Online-Ressource nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. 2005 Blackwell Publishing Journal Backfiles 1879-2005 |2005|||||||||| onychomycosis Leonardi, C verfasserin aut Stoltz, RR verfasserin aut Pierce, PF oth Conetta, B oth In European Academy of Dermatology and Venereology ; GKD-ID: 30105705 Journal of the European Academy of Dermatology and Venereology Oxford [u.a.] : Wiley-Blackwell, 1991 19(2005), 4, Seite 0 Online-Ressource (DE-627)NLEJ243926189 (DE-600)2022088-1 1468-3083 nnns volume:19 year:2005 number:4 pages:0 http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x text/html Verlag Deutschlandweit zugänglich Volltext GBV_USEFLAG_U ZDB-1-DJB GBV_NL_ARTICLE AR 19 2005 4 0 |
| source |
In Journal of the European Academy of Dermatology and Venereology 19(2005), 4, Seite 0 volume:19 year:2005 number:4 pages:0 |
| sourceStr |
In Journal of the European Academy of Dermatology and Venereology 19(2005), 4, Seite 0 volume:19 year:2005 number:4 pages:0 |
| format_phy_str_mv |
Article |
| institution |
findex.gbv.de |
| topic_facet |
onychomycosis |
| isfreeaccess_bool |
false |
| container_title |
Journal of the European Academy of Dermatology and Venereology |
| authorswithroles_txt_mv |
Gupta, AK @@aut@@ Leonardi, C @@aut@@ Stoltz, RR @@aut@@ Pierce, PF @@oth@@ Conetta, B @@oth@@ |
| publishDateDaySort_date |
2005-01-01T00:00:00Z |
| hierarchy_top_id |
NLEJ243926189 |
| id |
NLEJ243291884 |
| fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">NLEJ243291884</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230506104043.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">120427s2005 xx |||||o 00| ||und c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1111/j.1468-3083.2005.01212.x</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)NLEJ243291884</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Gupta, AK</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Oxford, UK</subfield><subfield code="b">Blackwell Science Ltd</subfield><subfield code="c">2005</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">z</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zu</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy.</subfield></datafield><datafield tag="533" ind1=" " ind2=" "><subfield code="d">2005</subfield><subfield code="f">Blackwell Publishing Journal Backfiles 1879-2005</subfield><subfield code="7">|2005||||||||||</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">onychomycosis</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Leonardi, C</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Stoltz, RR</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Pierce, PF</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Conetta, B</subfield><subfield code="4">oth</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="a">European Academy of Dermatology and Venereology ; GKD-ID: 30105705</subfield><subfield code="t">Journal of the European Academy of Dermatology and Venereology</subfield><subfield code="d">Oxford [u.a.] : Wiley-Blackwell, 1991</subfield><subfield code="g">19(2005), 4, Seite 0</subfield><subfield code="h">Online-Ressource</subfield><subfield code="w">(DE-627)NLEJ243926189</subfield><subfield code="w">(DE-600)2022088-1</subfield><subfield code="x">1468-3083</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:19</subfield><subfield code="g">year:2005</subfield><subfield code="g">number:4</subfield><subfield code="g">pages:0</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x</subfield><subfield code="q">text/html</subfield><subfield code="x">Verlag</subfield><subfield code="z">Deutschlandweit zugänglich</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-1-DJB</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_NL_ARTICLE</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">19</subfield><subfield code="j">2005</subfield><subfield code="e">4</subfield><subfield code="h">0</subfield></datafield></record></collection>
|
| series2 |
Blackwell Publishing Journal Backfiles 1879-2005 |
| author |
Gupta, AK |
| spellingShingle |
Gupta, AK misc onychomycosis A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| authorStr |
Gupta, AK |
| ppnlink_with_tag_str_mv |
@@773@@(DE-627)NLEJ243926189 |
| format |
electronic Article |
| delete_txt_mv |
keep |
| author_role |
aut aut aut |
| collection |
NL |
| publishPlace |
Oxford, UK |
| remote_str |
true |
| illustrated |
Not Illustrated |
| issn |
1468-3083 |
| topic_title |
A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis onychomycosis |
| publisher |
Blackwell Science Ltd |
| publisherStr |
Blackwell Science Ltd |
| topic |
misc onychomycosis |
| topic_unstemmed |
misc onychomycosis |
| topic_browse |
misc onychomycosis |
| format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
| format_main_str_mv |
Text Zeitschrift/Artikel |
| carriertype_str_mv |
zu |
| author2_variant |
p p pp b c bc |
| hierarchy_parent_title |
Journal of the European Academy of Dermatology and Venereology |
| hierarchy_parent_id |
NLEJ243926189 |
| hierarchy_top_title |
Journal of the European Academy of Dermatology and Venereology |
| isfreeaccess_txt |
false |
| familylinks_str_mv |
(DE-627)NLEJ243926189 (DE-600)2022088-1 |
| title |
A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| ctrlnum |
(DE-627)NLEJ243291884 |
| title_full |
A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| author_sort |
Gupta, AK |
| journal |
Journal of the European Academy of Dermatology and Venereology |
| journalStr |
Journal of the European Academy of Dermatology and Venereology |
| isOA_bool |
false |
| recordtype |
marc |
| publishDateSort |
2005 |
| contenttype_str_mv |
zzz |
| container_start_page |
0 |
| author_browse |
Gupta, AK Leonardi, C Stoltz, RR |
| container_volume |
19 |
| physical |
Online-Ressource |
| format_se |
Elektronische Aufsätze |
| author-letter |
Gupta, AK |
| doi_str_mv |
10.1111/j.1468-3083.2005.01212.x |
| author2-role |
verfasserin |
| title_sort |
a phase i/ii randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| title_auth |
A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| abstract |
Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. |
| abstractGer |
Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. |
| abstract_unstemmed |
Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy. |
| collection_details |
GBV_USEFLAG_U ZDB-1-DJB GBV_NL_ARTICLE |
| container_issue |
4 |
| title_short |
A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis |
| url |
http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x |
| remote_bool |
true |
| author2 |
Leonardi, C Stoltz, RR Pierce, PF Conetta, B |
| author2Str |
Leonardi, C Stoltz, RR Pierce, PF Conetta, B |
| ppnlink |
NLEJ243926189 |
| mediatype_str_mv |
z |
| isOA_txt |
false |
| hochschulschrift_bool |
false |
| author2_role |
oth oth |
| doi_str |
10.1111/j.1468-3083.2005.01212.x |
| up_date |
2024-07-06T04:58:20.228Z |
| _version_ |
1803804370774523904 |
| fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">NLEJ243291884</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230506104043.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">120427s2005 xx |||||o 00| ||und c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1111/j.1468-3083.2005.01212.x</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)NLEJ243291884</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Gupta, AK</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">A phase I/II randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and pharmacokinetics of ravuconazole in the treatment of onychomycosis</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Oxford, UK</subfield><subfield code="b">Blackwell Science Ltd</subfield><subfield code="c">2005</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">z</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zu</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Objective To determine the effectiveness and safety of ravuconazole in the treatment of toenail onychomycosis.Design A phase I/II randomized, double-blind, double-dummy, placebo-controlled, dose-ranging study. Four 12-week dosing regimens were used: 200 mg/day; 100 mg/week; 400 mg/week and placebo. Subjects returned at weeks 2, 4, 6, 8, 10, 12, 14, 16, 24, 36 and 48 for assessment. Subjects were enrolled at 10 dermatology practices (seven in the United States, one in Canada, two in France).Subjects Adults with distal subungual onychomycosis of one great (hallux) toenail (minimum area of 25%), and at least 2 mm of proximal nail clear of disease were selected. Onychomycosis was confirmed by direct microscopy and/or fungal culture. Subjects with conditions known to produce abnormal-appearing nails were excluded. One hundred and fifty-one subjects were randomized in a 2 : 2 : 2 : 1 ratio to the treatments above.Main Outcome Measures Primary efficacy was the effective cure rate at week 48 (mycological cure, and clinical cure or > 30% improvement).Results Effective cure was found in 56% of subjects using 200 mg/day. Effective cure was 10% in subjects receiving 100 mg/week, 8% of subjects using 400 mg/week, and 15% of subjects using placebo. Mycological cure was seen in 59% of subjects in the 200-mg/day group, which was significantly higher than the rates found in the other groups. Drug-related adverse events were infrequent in all treatment arms. Headache was the most frequently reported event. Abnormal laboratory tests were infrequent over the 12 weeks of dosing. Abnormal laboratory findings with increases beyond normal of Grade 2, 3 or 4 were found in 8/148 subjects (5.4%). Only the 200 mg daily regimen had a mean plasma steady state concentration of ravuconazole exceeding the MIC90 adjusted for 98% protein binding (3000 ng/mL).Conclusions For the treatment of onychomycosis, ravuconazole 200 mg/day for 12 weeks is the most effective of the regimens investigated. The safety of all regimens was acceptable. The concentrations of ravuconazole in the plasma compared to the adjusted MIC90 may be useful in predicting the clinical and mycologic response of therapy.</subfield></datafield><datafield tag="533" ind1=" " ind2=" "><subfield code="d">2005</subfield><subfield code="f">Blackwell Publishing Journal Backfiles 1879-2005</subfield><subfield code="7">|2005||||||||||</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">onychomycosis</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Leonardi, C</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Stoltz, RR</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Pierce, PF</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Conetta, B</subfield><subfield code="4">oth</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">In</subfield><subfield code="a">European Academy of Dermatology and Venereology ; GKD-ID: 30105705</subfield><subfield code="t">Journal of the European Academy of Dermatology and Venereology</subfield><subfield code="d">Oxford [u.a.] : Wiley-Blackwell, 1991</subfield><subfield code="g">19(2005), 4, Seite 0</subfield><subfield code="h">Online-Ressource</subfield><subfield code="w">(DE-627)NLEJ243926189</subfield><subfield code="w">(DE-600)2022088-1</subfield><subfield code="x">1468-3083</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:19</subfield><subfield code="g">year:2005</subfield><subfield code="g">number:4</subfield><subfield code="g">pages:0</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://dx.doi.org/10.1111/j.1468-3083.2005.01212.x</subfield><subfield code="q">text/html</subfield><subfield code="x">Verlag</subfield><subfield code="z">Deutschlandweit zugänglich</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_U</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-1-DJB</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_NL_ARTICLE</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">19</subfield><subfield code="j">2005</subfield><subfield code="e">4</subfield><subfield code="h">0</subfield></datafield></record></collection>
|
| score |
7.400216 |