EUCTR2009-015652-20-FR进行中（未招募）1 期
A 12-week, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of prucalopride in subjects with chronic non-cancer pain suffering from opioid induced constipation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Movetis NV
- 入组人数
- 174
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
- •Main inclusion criteria to be assessed at screening:
- •1. Subject is a male or non-pregnant, non-breastfeeding female out-patient =18 years of age (no upper age limit).
- •2. Subject has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids; has been on a stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on a stable daily dose of opioids for at least 15 weeks after Visit 1.
- •3. Subject is suffering from OIC (i.e. secondary to chronic opioid use), which is defined as having an average of =2 SBM/week and one or more of the following symptoms that started after initiating opioids:
- •a. Very hard (little balls) and/or hard stools at least a quarter of the stools.
- •b. Sensation of incomplete evacuation following at least a quarter of the stools.
- •c. Straining at defecation at least a quarter of the time.
- •The above criteria are only applicable for SBMs, i.e. bowel movements not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
- •Subjects who never have SBMs are considered to be constipated and are eligible for the trial.
- •4. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas].
- •Main inclusion criteria to be assessed at baseline (randomisation):
- •1. Subject has been taken a stable maintenance dose of opioids during the run-in period.
- •2. Subject is constipated, i.e. had an average of =2 SBM/week during the run-in period.*
- •3. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days of the run-in period.*
- •4. Subject did not use disallowed medication during the run-in period.
- •* Excluding the first 7 days for subjects using medication influencing bowel habit.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Constipation is thought to be drug-induced (except for opioids).
- •2. Disallowed medication is being used.
- •3. Subject was on chronic therapy for chronic constipation prior to the start of opioid therapy.
- •4. Subject is suffering from secondary causes of chronic constipation.
研究者
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