Prucalopride in Patients With Chronic Idiopathic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic idiopathic constipation.
Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic constipation shows a favourable effect on most of the efficacy parameters assessed in this trial. This dosage can be considered safe and generally well-tolerated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Study to Evaluate the Effect of a 1 mg o.d. Dose of Prucalopride in Patients With Chronic Idiopathic Constipation|
- Whole gut transit [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Ano-rectal physiology [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 1997|
|Study Completion Date:||March 1999|
|Primary Completion Date:||March 1999 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
1 mg o.d.
Other Name: Resolor
|Placebo Comparator: 2||
This is a randomized, double-blind, placebo-controlled, parallel-group, phase II trial set up to investigate the efficacy, safety and physiological effects of prucalopride 1 mg administered o.d. for 4 weeks to female patients with chronic idiopathic constipation. The primary objective of this trial was to assess the effect of prucalopride 1 mg on whole gut transit (measured as changes from baseline in total number of markers).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575614
|Principal Investigator:||Michael Kamm, MD||Northwick Park Hospital|