Efficacy and Safety Study of Prucalopride for the Re-Treatment of Chronic Constipation
|ClinicalTrials.gov Identifier: NCT00598338|
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : May 29, 2008
The purpose of this study is to determine whether prucalopride is safe and effective in the re-treatment of chronic constipation.
Retreatment is as effective and safe as treatment with prucalopride in patients with chronic constipation.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Prucalopride Other: Placebo||Phase 3|
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 4-week double-blind, placebo-controlled treatment period, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind treatment period.
During the initial run-in period, the subject's bowel habit will be documented in a daily diary and the existence of constipation will be confirmed. Eligible subjects will be randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given orally once daily before breakfast, for 4 weeks.
After 4 weeks of treatment, each subject will enter a drug-free washout period. The length of the washout period will be either 2 or 4 weeks, depending on how long it takes for the subject to meet the criteria for constipation. If the subject is unable to re-qualify after a 4-week washout, the subject must be discontinued from the trial.
Subjects who qualify for the second double-blind treatment period will receive the same treatment as during the first treatment period, once-daily for an additional four weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||516 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Two-Period, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of re-Treatment of Prucalopride on Efficacy and Safety in Subjects With Chronic Constipation.|
|Study Start Date :||April 1999|
|Primary Completion Date :||February 2000|
|Study Completion Date :||February 2000|
Active Comparator: 1
4 mg o.d.
Other Name: Resolor
Placebo Comparator: 2
- Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week. [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598338
|Principal Investigator:||Miner, Jr. B Miner, MD||Oklahoma Foundation for Digestive Research|