NCT01278082

SOIBD Collagenous Colitis Maintenance Study

Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules Versus Placebo for Maintenance of Remission in Patients With Collagenous Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period

Conditions

• Induction and Maintaining Remission of Collagenous Colitis

Interventions

Type	Name	Description
DRUG	Budesonide	Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
DRUG	Placebo	Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.

Timeline

• Start date: 2008-04-01
• Primary completion: 2013-03-01
• Completion: 2013-09-01
• First posted: 2011-01-17
• Last updated: 2016-01-21

Locations

2 sites across 2 countries: Germany, Sweden