Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation
|ClinicalTrials.gov Identifier: NCT00576511|
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : May 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: prucalopride Drug: placebo||Phase 2|
This is a phase II trial with a parallel-group design, consisting of a run-in phase (phase I), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 4 mg or placebo o.d. for a period of 4 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation determined. If the definition of constipation was not met during the 4 weeks of the run-in period, double-blind treatment will not be started.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 4 weeks with either 4 mg of R093877 or placebo given o.d. (two capsules of 2 mg are taken before breakfast).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation|
|Study Start Date :||December 1994|
|Primary Completion Date :||February 1996|
|Study Completion Date :||February 1996|
Active Comparator: 1
4 mg o.d.
Other Name: Resolor
|Placebo Comparator: 2||
- Constipation severity (VAS) [ Time Frame: 4 weeks ]
- Stool frequency (stool/week) [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576511
|Principal Investigator:||Georges Coremans, MD||Department of Gastroenterology, University Hospital Gasthuisberg, Catholic University Leuven, Leuven|