NCT00796354

Constipation Associated With Irritable Bowel Syndrome (IBS-C)

A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Movicol® With Placebo in Patients With Constipation Associated With Irritable Bowel Syndrome (IBS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.

Detailed description

Patients will be treated for 28 days, with clinical assessments carried out over 2 visits. Follow-up will be performed via telephone at a specific interval during the study to determine the outcome of unresolved AEs, any new drug-related AEs or any pregnancies. During the run-in period and the treatment phase, patients are prohibited from taking prescription or over the counter (OTC) laxative medication or constipating medications. Prescription and OTC medications not related to constipation are permitted and must be fully documented, but any changes (e.g., dosage, regimen) are to be limited as much as possible.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	MOVICOL	sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
DRUG	Sugar Pill	sealed laminated sachet, 1 - 3 sachets daily for 4 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-11-24
• Last updated: 2010-02-17

Locations

21 sites across 7 countries: Czechia, France, Germany, Italy, Poland, Sweden, United Kingdom