Clinical trial NCT00450086: Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Collagenous Colitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rate of clinical remission (<= 3 stools per day) after 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Rate of clinical remission (<= 3 stools per day) after 2 weeks
timeFrame: 2 weeks
measure: Time to remission
measure: Impact on stool consistency (watery/soft/solid)
timeFrame: 8 weeks
measure: Impact on abdominal pain
timeFrame: 8 weeks
measure: Impact on patient's general well-being
timeFrame: 8 weeks
measure: Effect on histopathology
timeFrame: 8 weeks
measure: Severity of diarrhea
timeFrame: 8 weeks
measure: QoL
timeFrame: 8 weeks
measure: PGA
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Center of digestive diseases
Study officials:
affiliation: Center for digestive diseases
name: Stephan Miehlke, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miehlke S, Madisch A, Kupcinskas L, Petrauskas D, Bohm G, Marks HJ, Neumeyer M, Nathan T, Fernandez-Banares F, Greinwald R, Mohrbacher R, Vieth M, Bonderup OK; BUC-60/COC Study Group. Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis. Gastroenterology. 2014 May;146(5):1222-30.e1-2. doi: 10.1053/j.gastro.2014.01.019. Epub 2014 Jan 15.