At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation
In Brief
A Phase 3 clinical trial evaluating Placebo and Prucalopride for Male Subjects With Chronic Constipation. Completed, enrolled 374 participants across 73 sites in 10 countries.
Detailed Summary
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation. Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.
Study Details
Timeline
Interventions
Placebo matched to Prucalopride tablet orally once daily.
Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (\<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.