NCT01459926已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
研究概览
简要总结
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of constipation with onset after initiation of opioid therapy
- •Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period
- •Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the Screening Visit
- •Willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation, treatment, and follow-up periods
排除标准
- •Have participated in a clinical trial of an investigational drug or medical device within 30 days prior to Screening
- •Have any condition that may affect drug absorption, (e.g., previous GI surgery)
- •Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol
研究组 & 干预措施
Dose 3
Experimental
干预措施: TD-1211 (Drug)
Dose 1
Experimental
干预措施: TD-1211 (Drug)
Placebo
Experimental
干预措施: Placebo (Drug)
Dose 2
Experimental
干预措施: TD-1211 (Drug)
结局指标
主要结局
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
时间窗: Between weeks 2 and 5
次要结局
- Change from baseline in the weekly SBM frequency in the last week of treatment(baseline and 5 weeks)
研究者
研究点 (2)
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