The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients. Hypothesis: 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
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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
303
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
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