NCT01401985已完成2 期
A Single-Blind, Pilot Study to Determine the Tolerability and Safety 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
- 95
- 试验地点
- 2
- 主要终点
- Safety and tolerability of TD-1211
研究概览
简要总结
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •stable dose of opioids for at least 12 weeks before screening visit
- •less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
- •willing to stop laxatives and other bowel treatments; rescue laxative allowed
排除标准
- •Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
- •Have participated in another clinical trial of an investigational drug 30 days prior to screening
- •History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
- •History of chronic constipation prior to opioid therapy
- •Females who are pregnant or breast feeding
- •Have any condition that may affect drug absorption (e.g. previous GI surgery)
研究组 & 干预措施
Cohort 1
Experimental
5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
干预措施: TD-1211 (Drug)
Cohort 6
Experimental
2.5 mg TD-1211 every 6 hours for 14 days
干预措施: TD-1211 (Drug)
Cohort 3
Experimental
5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
干预措施: TD-1211 (Drug)
Cohort 5
Experimental
2 mg TD-1211 once daily for 14 days
干预措施: Placebo (Drug)
Cohort 6
Experimental
2.5 mg TD-1211 every 6 hours for 14 days
干预措施: Placebo (Drug)
Cohort 5
Experimental
2 mg TD-1211 once daily for 14 days
干预措施: TD-1211 (Drug)
Cohort 2
Experimental
5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
干预措施: TD-1211 (Drug)
Cohort 4
Experimental
5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
干预措施: TD-1211 (Drug)
结局指标
主要结局
Safety and tolerability of TD-1211
时间窗: 14 days
次要结局
- Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)(Weekly assessments throughout Treatment Period)
研究者
研究点 (2)
Loading locations...
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