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

Sponsored by:	Dr. Falk Pharma GmbH
Information provided by:	Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00450086

Purpose

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

Condition	Intervention	Phase
Collagenous Colitis	Drug: Budesonide Drug: Mesalazine Drug: Placebo	Phase III

Drug Information available for: Mesalamine Budesonide

U.S. FDA Resources

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

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	96
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Budesonide 9 mg per day
B: Experimental	Drug: Mesalazine 3 g per day
C: Placebo Comparator	Drug: Placebo 0 g per day

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450086

Contacts

Contact: Ralf Mohrbacher

++49 761 1514-0 ext -156

mohrbacher@drfalkpharma.de

Locations

Germany
Medical Department I, University Hospital Carl Gustav Carus, Technical University	Recruiting
Dresden, Germany, 01307
Contact: Stephan Miehlke, Professor ++49 351 458-0 ext -5645 stephan.miehlke@uniklinikum-dresden.de
Contact: Ahmed Madisch, MD ++49 351 458-0 ext -5645 ahmed.madisch@uniklinikum-dresden.de

Sponsors and Collaborators

Dr. Falk Pharma GmbH

Investigators

Principal Investigator:

Stephan Miehlke, Professor

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

More Information

Responsible Party:	( Dr. Falk Pharma GmbH )
Study ID Numbers:	BUC-60/COC, 2006-004159-39
Study First Received:	March 20, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00450086
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Colitis, Microscopic
Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Colonic Diseases
Budesonide

Collagenous colitis
Colitis, Collagenous
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Sensory System Agents

Analgesics, Non-Narcotic
Autonomic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009