Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis (NCT00450086) | Clinical Trial Compass
CompletedPhase 3
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
Germany92 participantsStarted 2007-03
Plain-language summary
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Rate of clinical remission (<= 3 stools per day) after 8 weeks