At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 620 enrolled
Drug / intervention
Prucalopride +2 moredrug
Likely dose
Prucalopride 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.
In Brief
A Phase 3 clinical trial evaluating Prucalopride and Placebo for Constipation. Completed, enrolled 620 participants.
Detailed Summary
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation. 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 1998
Primary CompletionMay 1999
First PostedJun 2007
TodayJul 2026
First PostedJun 7, 2007
Enrollment StartApr 1, 1998
Primary CompletionMay 1, 1999
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.1 years ago
Interventions
Prucalopridedrug
2 mg o.d.
Placeboother
Placebo o.d.
Prucalopridedrug
4 mg o.d.