Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation.
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation|
- Proportion of subjects with an average of 3 or more SCBM per week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Secondary efficacy variables: 1) Symptom variables 2) QOL variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 1998|
|Study Completion Date:||July 1999|
|Primary Completion Date:||July 1999 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Prucalopride 2 mg
2 mg o.d.
Other Name: Resolor
Placebo Comparator: 3
Active Comparator: 2
Prucalopride 4 mg
4 mg o.d.
Other Name: Resolor
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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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 should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to visit 2) and 48 hours following the start of double-blind treatment (48 hours following visit 2). 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.