Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

Phase 3

Completed

• Conditions: Collagenous Colitis
• Interventions: Drug: Budesonide; Drug: Placebo; Drug: Mesalazine

• Registration Number: NCT00450086
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

Detailed Description

This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-20
• Study First Submitted QC: 2007-03-20
• Study First Posted: 2007-03-21
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

• Evidence of infectious diarrhea
• Celiac disease
• Endoscopic-histologic findings, which may have caused diarrhea
• History of partial colonic resection
• Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
• Active colorectal cancer or a history of colorectal cancer
• Severe co-morbidity substantially reducing life expectancy
• Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
• Abnormal renal function (Cystatin C > ULN)
• Active peptic ulcer disease, local intestinal infection
• Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
• Hemorrhagic diathesis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Budesonide	-
C	Placebo	-
B	Mesalazine	-

Primary Outcome Measures

Name	Time	Method
Rate of clinical remission (<= 3 stools per day) after 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of clinical remission (<= 3 stools per day) after 2 weeks	2 weeks
Time to remission
Impact on stool consistency (watery/soft/solid)	8 weeks
Impact on abdominal pain	8 weeks
Impact on patient's general well-being	8 weeks
Effect on histopathology	8 weeks
Severity of diarrhea	8 weeks
QoL	8 weeks
PGA	8 weeks

Trial Locations

Locations (1)

Center of digestive diseases; 🇩🇪 Hamburg, Germany