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 weeksTime 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
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