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Sponsored by: |
Movetis |
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Information provided by: | Movetis |
ClinicalTrials.gov Identifier: | NCT00485940 |
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation
Hypothesis:
Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients
Condition | Intervention | Phase |
---|---|---|
Constipation |
Drug: Prucalopride Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation |
Enrollment: | 641 |
Study Start Date: | March 1998 |
Study Completion Date: | May 1999 |
Primary Completion Date: | May 1999 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Prucalopride 2 mg
|
Drug: Prucalopride
2 mg o.d.
|
3: Placebo Comparator
Placebo
|
Other: Placebo
Placebo o.d.
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2: Active Comparator
Prucalopride 4 mg
|
Drug: Prucalopride
4 mg o.d.
|
This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 12-week, double-blind, placebo-controlled treatment period.
During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative (Dulcolax) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. No Dulcolax or enemas should be taken within 48 hours prior to the start of double-blind treatment and 48 hours following the start of double-blind treatment. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period.
If the definition of constipation is not met during the 2-week run-in, the subject will be considered ineligible for the double-blind period and will be discontinued from the study.
During the double-blind, randomised, placebo-controlled period, subjects will be treated for 12 weeks with either 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
History of constipation; the subject reports, ona average,two of fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.
Exclusion Criteria:
Responsible Party: | Movetis ( Renate Specht Gryp ) |
Study ID Numbers: | PRU-USA-13 |
Study First Received: | June 12, 2007 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00485940 |
Health Authority: | United States: Institutional Review Board |
constipation prucalopride QOL SCBM PAC-SYM |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |