Constipation Clinical Trial
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
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be withdrawn and subjects will be instructed not to change their diet or lifestyle during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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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