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Sponsored by: |
Movetis |
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Information provided by: | Movetis |
ClinicalTrials.gov Identifier: | NCT00617513 |
The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic idiopathic constipation.
Hypothesis:
Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic constipation whereas 0,5 mg is a suboptimal dose.
Condition | Intervention | Phase |
---|---|---|
Constipation |
Drug: Prucalopride Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation |
Enrollment: | 174 |
Study Start Date: | March 1995 |
Study Completion Date: | March 1996 |
Primary Completion Date: | March 1996 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Prucalopride
0.5 mg once daily
|
2: Active Comparator |
Drug: Prucalopride
1 mg o.d.
|
3: Active Comparator |
Drug: Prucalopride
2 mg o.d.
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4: Placebo Comparator |
Other: Placebo
o.d.
|
This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 0.5 mg o.d., 1 mg o.d. or 2 mg o.d. or placebo 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 confirmed. At the start of this period all existing laxative medication is withdrawn but patients will be instructed not to change their dietary habits, in particular their fibre intake during the trial.
Patients will enter the double-blind phase if constipation has been shown to be present during the run-in period. 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 0.5 mg, 1 mg or 2 mg of R093877 or placebo given once daily (one capsule is taken before breakfast). Patients admitted to the double blind treatment period will be randomly allocated to one of the 4 treatment arms.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of constipation i.e., the patient reported the occurrence of TWO OR MORE of the following criteria for at least 6 months before the selection visit :
straining at defaecation at least a quarter of the time.
Exclusion Criteria:
Responsible Party: | Movetis ( Renate Specht Gryp ) |
Study ID Numbers: | PRU-INT-1 |
Study First Received: | February 6, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00617513 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |