NCT01333540已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Clinical Activity 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
- 69
- 试验地点
- 1
- 主要终点
- Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211
研究概览
简要总结
A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients 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
- Double (Participant, Investigator)
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
- •Males and females between 18 and 65 years of age, inclusive
- •Subjects with documented OIC on stable opioid regimen
- •Willingness to stop all laxatives throughout run-in and treatment period
排除标准
- •Any clinically significant findings in subjects with OIC
- •Have participated in another clinical trial of an investigational drug 30 days prior to screening
- •History of chronic constipation prior to opioid therapy in OIC subjects
- •Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Active
Experimental
Escalating Doses of TD-1211
干预措施: TD-1211 (Drug)
结局指标
主要结局
Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211
时间窗: Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks
次要结局
- Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels(Continuous assessments for up to six weeks)
研究者
研究点 (1)
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