At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 368 enrolled
Drug / intervention
Bisacodyl 10 mg +1 moredrug
Likely dose
Bisacodyl 10 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 Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Bisacodyl (Dulcolax) Tablets 10mg Administered Orally, Once Daily, in Patients With Functional Constipation.
In Brief
A Phase 3 clinical trial evaluating Bisacodyl 10 mg and Placebo for Constipation. Completed, enrolled 368 participants across 27 sites.
Detailed Summary
The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedSep 2007
Primary CompletionJun 2009
TodayJul 2026
First PostedSep 6, 2007
Enrollment StartSep 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.8 years ago
Interventions
Bisacodyl 10 mgdrug
2 x 5 mg bisacodyl once daily
Placebodrug
Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily