Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|