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

Collagenous Colitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450086
• Other study ID #: BUC-60/COC
• Secondary ID: 2006-004159-39
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2007
• Last updated: May 16, 2014
• Start date: March 2007
• Est. completion date: August 2011

Study information

• Verified date: May 2014
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Collagenous Colitis

Intervention

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

Locations

Country	Name	City	State
Germany	Center of digestive diseases	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Miehlke S, Madisch A, Kupcinskas L, Petrauskas D, Böhm G, Marks HJ, Neumeyer M, Nathan T, Fernández-Bañares F, Greinwald R, Mohrbacher R, Vieth M, Bonderup OK; BUC-60/COC Study Group. Budesonide is more effective than mesalamine or placebo in short-term t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinical remission (<= 3 stools per day) after 8 weeks		8 weeks	No
Secondary	Rate of clinical remission (<= 3 stools per day) after 2 weeks		2 weeks	No
Secondary	Time to remission			No
Secondary	Impact on stool consistency (watery/soft/solid)		8 weeks	No
Secondary	Impact on abdominal pain		8 weeks	No
Secondary	Impact on patient's general well-being		8 weeks	No
Secondary	Effect on histopathology		8 weeks	No
Secondary	Severity of diarrhea		8 weeks	No
Secondary	QoL		8 weeks	No
Secondary	PGA		8 weeks	No