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Bisacodyl for Functional Constipation
NCT00526097Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2007
- Primary completion
- Jun 2009
- Countries
- 1
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- bisacodyl
- Conditions
- functional constipation (FC)
01
Overview
Phase 3, randomised, double-blind trial in functional constipation (FC) comparing Bisacodyl with Placebo (2 arms). Primary endpoint: Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week at 4 weeks. Started Sep 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Bisacodyl
Bisacodyl 10 mg (2 x 5 mg) once daily
Placebo
Placebo matching Bisacodyl once daily
03
Who it enrols
Adult patients with functional constipation defined by Rome III criteria, excluding those with organic causes, eating disorders, or taking opioids.
04
Endpoints
Primary
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week
Secondary
Number of CSBMs at Week 1
Number of CSBMs at Week 2
Number of CSBMs at Week 3
Number of CSBMs at Week 4
Mean Number of Spontaneous Bowel Movements (SBMs) Per Week
Time to the First SBM Following the First Dose of Study Medication
Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week
Number of Participants With a Mean of at Least 1 CSBM a Day
05
Results
Primary endpoints met
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