EUCTR2013-002949-11-DE进行中（未招募）1 期
A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy - COMPOSE III
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects aged 18 to 80 years inclusive at the time of informed consent
- •2. Subjects must have non-malignant chronic pain and must have OIC
- •3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of = 30 mg equivalents of oral morphine sulfate
- •4. Subjects may or may not be on a routine laxative regimen at the time of Screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
- •a. history of bowel obstructions, strictures
- •b. history of bowel surgery such as bowel resection or bariatric surgeries
- •2. Evidence of active medical diseases affecting bowel transit
- •3. History of pelvic disorders that may be a cause of constipation
- •4. Surgery (except for minor procedures) within 60 days of Screening
- •5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical gastrointestinal obstruction)
- •6. Subjects who have never taken laxatives for the treatment of OIC
- •7. Current use of any prohibited medication listed including opioid antagonists, partial agonists or mixed opioid agonists/antagonists
研究者
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