Status:
COMPLETED
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Collagenous Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 plac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00450086
Start Date
March 1 2007
End Date
August 1 2011
Last Update
May 19 2014
Active Locations (1)
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1
Center of digestive diseases
Hamburg, Germany, 20249