Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients.
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
|Constipation||Drug: prucalopride Drug: Prucalopride Other: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation|
- Proportion of subjects with an average of 3 or more SCBM per week [ Time Frame: 12 weeks ]
- Secondary efficacy variables: 1)Symptom variables 2)QOL variables [ Time Frame: 12 weeks ]
|Study Start Date:||October 1998|
|Study Completion Date:||September 1999|
|Primary Completion Date:||September 1999 (Final data collection date for primary outcome measure)|
Active Comparator: 1
2 mg o.d.
Other Name: Resolor
Active Comparator: 2
4 mg o.d.
Other Name: Resolor
Placebo Comparator: 3
This is a multicentre, randomised, 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.
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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group.
During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487422
|Principal Investigator:||Gerald Demschik, M.D.||Geriatriezentrum am Wienerwald|