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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide; Mesalamine

Criteria

Inclusion Criteria (main):

• > 4 watery/soft stools on at least 4 days in the week prior to baseline

• > 3 stools per day on average within the last 7 days prior to baseline

• Symptoms (chronic watery diarrhea) for at least 3 months before baseline

• Complete colonoscopy within the last 12 weeks before baseline

• Histologically confirmed diagnosis of collagenous colitis

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