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

Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Collagenous Colitis

Intervention: Budesonide (Drug); Mesalazine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dr. Falk Pharma GmbH

Official(s) and/or principal investigator(s):
Stephan Miehlke, Professor, Principal Investigator, Affiliation: Center for digestive diseases

Summary

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of clinical remission (<= 3 stools per day) after 8 weeks

Secondary outcome:

Rate of clinical remission (<= 3 stools per day) after 2 weeks

Time to remission

Impact on stool consistency (watery/soft/solid)

Impact on abdominal pain

Impact on patient's general well-being

Effect on histopathology

Severity of diarrhea

QoL

PGA

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Center of digestive diseases, Hamburg 20249, Germany
Additional Information

Starting date: March 2007
Last updated: May 16, 2014

Page last updated: August 23, 2015

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