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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-08-31

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.

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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.

Conditions

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Collagenous Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

9 mg per day

B

Group Type EXPERIMENTAL

Mesalazine

Intervention Type DRUG

3 g per day

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 g per day

Interventions

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Budesonide

9 mg per day

Intervention Type DRUG

Mesalazine

3 g per day

Intervention Type DRUG

Placebo

0 g per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \> 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No