Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 20, 2007

Last Updated Date

July 24, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rate of clinical remission (<= 3 stools per day) after 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Rate of clinical remission (<= 3 stools per day) after 8 weeks

Change History

Complete list of historical versions of study NCT00450086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Collagenous Colitis

Intervention ^ICMJE

Drug: Budesonide
Drug: Mesalazine
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ralf Mohrbacher

++49 761 1514-0 ext -156

mohrbacher@drfalkpharma.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00450086

Responsible Party

Dr. Falk Pharma GmbH

Study ID Numbers ^ICMJE

BUC-60/COC, 2006-004159-39

Study Sponsor ^ICMJE

Dr. Falk Pharma GmbH

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Stephan Miehlke, Professor

Medical Department I, University Hospital Carl Gustav Carus, Technical University, Dresden, Germany

Information Provided By

Dr. Falk Pharma GmbH

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP