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

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

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

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 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.

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

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

Starting date: March 2007
Ending date: July 2009
Last updated: July 24, 2009