Efficacy and Safety Study of Prucalopride for the Re-Treatment of Chronic Constipation
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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.|
- Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 1999|
|Study Completion Date:||February 2000|
|Primary Completion Date:||February 2000 (Final data collection date for primary outcome measure)|
Active Comparator: 1
4 mg o.d.
Other Name: Resolor
Placebo Comparator: 2
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.