Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study
Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Yu, Shiying [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2014transfer abstract |
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| Schlagwörter: |
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| Umfang: |
10 |
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| Übergeordnetes Werk: |
Enthalten in: Reliable redundancy resolution strategies for kinematically redundant parallel manipulators - Vieira, Hiparco Lins ELSEVIER, 2021, official journal of the American Pain Society, New York, NY |
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| Übergeordnetes Werk: |
volume:15 ; year:2014 ; number:8 ; pages:835-844 ; extent:10 |
| Links: |
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| DOI / URN: |
10.1016/j.jpain.2014.04.008 |
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| 245 | 1 | 0 | |a Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study |
| 264 | 1 | |c 2014transfer abstract | |
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| 520 | |a Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. | ||
| 520 | |a Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. | ||
| 650 | 7 | |a cancer pain |2 Elsevier | |
| 650 | 7 | |a hydromorphone extended-release |2 Elsevier | |
| 650 | 7 | |a oxycodone |2 Elsevier | |
| 650 | 7 | |a strong opioids |2 Elsevier | |
| 650 | 7 | |a Brief Pain Inventory |2 Elsevier | |
| 700 | 1 | |a Shen, Wei |4 oth | |
| 700 | 1 | |a Yu, Lu |4 oth | |
| 700 | 1 | |a Hou, Yanyan |4 oth | |
| 700 | 1 | |a Han, John |4 oth | |
| 700 | 1 | |a Richards, Henry M. |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |n Elsevier |a Vieira, Hiparco Lins ELSEVIER |t Reliable redundancy resolution strategies for kinematically redundant parallel manipulators |d 2021 |d official journal of the American Pain Society |g New York, NY |w (DE-627)ELV006838596 |
| 773 | 1 | 8 | |g volume:15 |g year:2014 |g number:8 |g pages:835-844 |g extent:10 |
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10.1016/j.jpain.2014.04.008 doi GBVA2014005000004.pica (DE-627)ELV01733084X (ELSEVIER)S1526-5900(14)00720-2 DE-627 ger DE-627 rakwb eng 610 610 DE-600 620 VZ 52.20 bkl 50.32 bkl 50.25 bkl Yu, Shiying verfasserin aut Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study 2014transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. cancer pain Elsevier hydromorphone extended-release Elsevier oxycodone Elsevier strong opioids Elsevier Brief Pain Inventory Elsevier Shen, Wei oth Yu, Lu oth Hou, Yanyan oth Han, John oth Richards, Henry M. oth Enthalten in Elsevier Vieira, Hiparco Lins ELSEVIER Reliable redundancy resolution strategies for kinematically redundant parallel manipulators 2021 official journal of the American Pain Society New York, NY (DE-627)ELV006838596 volume:15 year:2014 number:8 pages:835-844 extent:10 https://doi.org/10.1016/j.jpain.2014.04.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 52.20 Antriebstechnik Getriebelehre VZ 50.32 Dynamik Schwingungslehre Technische Mechanik VZ 50.25 Robotertechnik VZ AR 15 2014 8 835-844 10 045F 610 |
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10.1016/j.jpain.2014.04.008 doi GBVA2014005000004.pica (DE-627)ELV01733084X (ELSEVIER)S1526-5900(14)00720-2 DE-627 ger DE-627 rakwb eng 610 610 DE-600 620 VZ 52.20 bkl 50.32 bkl 50.25 bkl Yu, Shiying verfasserin aut Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study 2014transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. cancer pain Elsevier hydromorphone extended-release Elsevier oxycodone Elsevier strong opioids Elsevier Brief Pain Inventory Elsevier Shen, Wei oth Yu, Lu oth Hou, Yanyan oth Han, John oth Richards, Henry M. oth Enthalten in Elsevier Vieira, Hiparco Lins ELSEVIER Reliable redundancy resolution strategies for kinematically redundant parallel manipulators 2021 official journal of the American Pain Society New York, NY (DE-627)ELV006838596 volume:15 year:2014 number:8 pages:835-844 extent:10 https://doi.org/10.1016/j.jpain.2014.04.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 52.20 Antriebstechnik Getriebelehre VZ 50.32 Dynamik Schwingungslehre Technische Mechanik VZ 50.25 Robotertechnik VZ AR 15 2014 8 835-844 10 045F 610 |
| allfields_unstemmed |
10.1016/j.jpain.2014.04.008 doi GBVA2014005000004.pica (DE-627)ELV01733084X (ELSEVIER)S1526-5900(14)00720-2 DE-627 ger DE-627 rakwb eng 610 610 DE-600 620 VZ 52.20 bkl 50.32 bkl 50.25 bkl Yu, Shiying verfasserin aut Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study 2014transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. cancer pain Elsevier hydromorphone extended-release Elsevier oxycodone Elsevier strong opioids Elsevier Brief Pain Inventory Elsevier Shen, Wei oth Yu, Lu oth Hou, Yanyan oth Han, John oth Richards, Henry M. oth Enthalten in Elsevier Vieira, Hiparco Lins ELSEVIER Reliable redundancy resolution strategies for kinematically redundant parallel manipulators 2021 official journal of the American Pain Society New York, NY (DE-627)ELV006838596 volume:15 year:2014 number:8 pages:835-844 extent:10 https://doi.org/10.1016/j.jpain.2014.04.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 52.20 Antriebstechnik Getriebelehre VZ 50.32 Dynamik Schwingungslehre Technische Mechanik VZ 50.25 Robotertechnik VZ AR 15 2014 8 835-844 10 045F 610 |
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10.1016/j.jpain.2014.04.008 doi GBVA2014005000004.pica (DE-627)ELV01733084X (ELSEVIER)S1526-5900(14)00720-2 DE-627 ger DE-627 rakwb eng 610 610 DE-600 620 VZ 52.20 bkl 50.32 bkl 50.25 bkl Yu, Shiying verfasserin aut Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study 2014transfer abstract 10 nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. cancer pain Elsevier hydromorphone extended-release Elsevier oxycodone Elsevier strong opioids Elsevier Brief Pain Inventory Elsevier Shen, Wei oth Yu, Lu oth Hou, Yanyan oth Han, John oth Richards, Henry M. oth Enthalten in Elsevier Vieira, Hiparco Lins ELSEVIER Reliable redundancy resolution strategies for kinematically redundant parallel manipulators 2021 official journal of the American Pain Society New York, NY (DE-627)ELV006838596 volume:15 year:2014 number:8 pages:835-844 extent:10 https://doi.org/10.1016/j.jpain.2014.04.008 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 52.20 Antriebstechnik Getriebelehre VZ 50.32 Dynamik Schwingungslehre Technische Mechanik VZ 50.25 Robotertechnik VZ AR 15 2014 8 835-844 10 045F 610 |
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Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study |
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Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. |
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Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. |
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Noninferiority of the efficacy of once-daily hydromorphone hydrochloride extended-release (hydromorphone ER) compared with twice-daily oxycodone hydrochloride controlled-release (oxycodone CR) was investigated in this randomized, double-blind study in Chinese patients with moderate to severe cancer pain requiring strong oral opioid analgesics. Randomization (1:1) to hydromorphone ER (8–32 mg) or oxycodone CR (10–40 mg) was followed by dose titration (up to 8 days) and dose maintenance (28 days, weekly visits). Primary endpoint was change from baseline to end of study in “worst pain in the past 24 hours” of Brief Pain Inventory (Short Form) score on last observation carried forward (per protocol set). A total of 137 of 260 randomized patients completed maintenance phase (hydromorphone ER: n = 70; oxycodone CR: n = 67); per protocol set: 81 patients. Mean age was 53.1 years (range: 18–70 years; males: 65.3%); most common Eastern Cooperative Oncology Group performance status = 2. Least square mean difference between 2 treatment groups for primary endpoint using analysis of covariance (baseline score, covariate) was −.1 (95% confidence interval: −1.3, 1.1), with upper bound of 95% confidence interval <1.5 (predefined noninferiority margin). Most common reason for deaths was disease progression (hydromorphone ER: 6.3%; oxycodone CR: 12.7%). Treatment-emergent adverse events were comparable between treatment groups. Hydromorphone ER was noninferior to oxycodone CR in alleviating cancer pain and was well tolerated. |
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Safety and Efficacy of Once-Daily Hydromorphone Extended-Release Versus Twice-Daily Oxycodone Hydrochloride Controlled-Release in Chinese Patients With Cancer Pain: A Phase 3, Randomized, Double-Blind, Multicenter Study |
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https://doi.org/10.1016/j.jpain.2014.04.008 |
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Shen, Wei Yu, Lu Hou, Yanyan Han, John Richards, Henry M. |
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10.1016/j.jpain.2014.04.008 |
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2024-07-06T21:43:02.786Z |
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