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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Collagenous Colitis

Intervention / Treatment
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* Drug: Budesonide
* Drug: Mesalazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Budesonide<br>* 9 mg per day<br>|
| Experimental: B<br> | Drug: Mesalazine<br>* 3 g per day<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* 0 g per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission (<= 3 stools per day) after 8 weeks |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission (<= 3 stools per day) after 2 weeks |  | 2 weeks | 
| Time to remission |  |  | 
| Impact on stool consistency (watery/soft/solid) |  | 8 weeks | 
| Impact on abdominal pain |  | 8 weeks | 
| Impact on patient's general well-being |  | 8 weeks | 
| Effect on histopathology |  | 8 weeks | 
| Severity of diarrhea |  | 8 weeks | 
| QoL |  | 8 weeks | 
| PGA |  | 8 weeks |