Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
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The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
Condition or disease
Drug: BudesonideDrug: MesalazineDrug: Placebo
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs. Mesalazine Granules vs. Placebo for Patients With Collagenous Colitis.
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Evidence of infectious diarrhea
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