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.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Budesonide
  • 9 mg per day
• Drug: Mesalazine
  • 3 g per day
• Drug: Placebo
  • 0 g per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Placebo Comparator: C

Primary Measures

• Rate of clinical remission (<= 3 stools per day) after 8 weeks
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Rate of clinical remission (<= 3 stools per day) after 2 weeks
  • Time Frame: 2 weeks
    Safety Issue?: No
• Time to remission
  • Safety Issue?: No
• Impact on stool consistency (watery/soft/solid)
  • Time Frame: 8 weeks
    Safety Issue?: No
• Impact on abdominal pain
  • Time Frame: 8 weeks
    Safety Issue?: No
• Impact on patient's general well-being
  • Time Frame: 8 weeks
    Safety Issue?: No
• Effect on histopathology
  • Time Frame: 8 weeks
    Safety Issue?: No
• Severity of diarrhea
  • Time Frame: 8 weeks
    Safety Issue?: No
• QoL
  • Time Frame: 8 weeks
    Safety Issue?: No
• PGA
  • Time Frame: 8 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dr. Falk Pharma GmbH

Overall Clinical Trial Officials and Contacts

Stephan Miehlke, Professor Principal Investigator Medical Department I, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany  

Overall Contact: Ralf Mohrbacher ++49 761 1514-0 mohrbacher@drfalkpharma.de

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00450086

Study ID Number: BUC-60/COC

ClinicalTrials.gov Identifier: NCT00450086

Health Authority: Germany: Federal Institute for Drugs and Medical Devices