EUCTR2009-015719-42-GB进行中（未招募）1 期
A 12-week, randomised, double-blind, placebo controlled trial to evaluate the efficacy, quality of life, safety and tolerability of prucalopride in male subjects with chronic constipation
Shire-Movetis NV0 个研究点目标入组 374 人开始时间: 2010年6月17日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 374
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
入选标准
- •Main inclusion criteria to be assessed at screening:
- •1. Subject is a male out-patient =18 years of age (no upper age limit).
- •2. Subject has a history of constipation, i.e. reports an average of =2 spontaneous bowel movements (SBM)/week that result in a feeling of complete evacuation (SCBM) and one or more of the following for at least 6 months before the selection visit:
- •a) Very hard (little balls) and/or hard stools for at least a quarter of the stools;
- •b) Sensation of incomplete evacuation following for at least a quarter of stools;
- •c) Straining at defecation for at least a quarter of the time.
- •The above criteria are only applicable for SBMs, i.e. BMs 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.
- •3. Subject agrees to stop his current laxative treatment and is willing to use rescue.
- •Main inclusion criteria to be assessed at baseline (randomisation):
- •1. During the run-in period, the subject reports an average of =2 SBM/week that result in a feeling of complete evacuation (SCBM).* This includes subjects who never have SBMs.
- •2. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days during the run-in period.* medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas].
- •3. Subject did not use disallowed medication during the run-in period.
- •* Excluding the first 7 days for subjects using medication influencing bowel habit or excluding the days between screening and the 7 days following the colonoscopy/sigmoidoscopy for those who had a colonoscopy/sigmoidoscopy after 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 334
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. Subjects in whom constipation is thought to be drug-induced.
- •2. Subjects using any disallowed medication.
- •3. Subjects suffering from secondary causes of chronic constipation.
研究者
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