Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
Information source: Dr. Falk Pharma GmbH
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Collagenous Colitis
Intervention: Budesonide (Drug); Mesalazine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Dr. Falk Pharma GmbH Official(s) and/or principal investigator(s):
Stephan Miehlke, Professor, Principal Investigator, Affiliation: Medical Department I, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany
Overall contact:
Ralf Mohrbacher, Phone: ++49 761 1514-0, Ext: -156, Email: mohrbacher@drfalkpharma.de
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Ralf Mohrbacher, Phone: ++49 761 1514-0, Ext: -156, Email: mohrbacher@drfalkpharma.de
Medical Department I, University Hospital Carl Gustav Carus, Technical University, Dresden 01307, Germany; Recruiting
Stephan Miehlke, Professor, Phone: ++49 351 458-0, Ext: -5645, Email: stephan.miehlke@uniklinikum-dresden.de
Ahmed Madisch, MD, Phone: ++49 351 458-0, Ext: -5645, Email: ahmed.madisch@uniklinikum-dresden.de
Additional Information
Starting date: March 2007
Ending date: July 2009
Last updated: May 29, 2008
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