EUCTR2011-000670-62-HU进行中（未招募）不适用
A randomised, double-blind, placebo-controlled trial to evaluate the efficacy, quality of life, safety and tolerability of long-term treatment (24 weeks) with prucalopride in subjects aged =18 years with chronic constipation.
Shire-Movetis NV0 个研究点目标入组 360 人开始时间: 2011年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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 a history of constipation. The subject reports an average of =2 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 at least a quarter of the
- •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. 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/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl (Dulcolax®)/enemas]
- •Main inclusion criteria to be assessed at randomisation:
- •1. During the run-in phase the subject reports an average of =2 SBM/week that result in a feeling of complete evacuation (SCBM).
- •2. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days during the run-in phase.
- •3. Subject did not use disallowed medication during the run-in phase.
- •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 295
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •Main exclusion criteria to be assessed at screening:
- •1. Subjects in whom constipation is thought to be drug-induced
- •2. Subjects using any disallowed medication.
- •3. Subjects who previously used prucalopride.
- •4. Subjects suffering from secondary causes of chronic constipation
研究者
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