- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00450086
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
May 16, 2014 updated by: Dr. Falk Pharma GmbH
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hamburg, Germany, 20249
- Center of digestive diseases
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: C
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0 g per day
|
Experimental: A
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9 mg per day
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Experimental: B
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3 g per day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of clinical remission (<= 3 stools per day) after 8 weeks
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of clinical remission (<= 3 stools per day) after 2 weeks
Time Frame: 2 weeks
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2 weeks
|
Time to remission
|
|
Impact on stool consistency (watery/soft/solid)
Time Frame: 8 weeks
|
8 weeks
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Impact on abdominal pain
Time Frame: 8 weeks
|
8 weeks
|
Impact on patient's general well-being
Time Frame: 8 weeks
|
8 weeks
|
Effect on histopathology
Time Frame: 8 weeks
|
8 weeks
|
Severity of diarrhea
Time Frame: 8 weeks
|
8 weeks
|
QoL
Time Frame: 8 weeks
|
8 weeks
|
PGA
Time Frame: 8 weeks
|
8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephan Miehlke, Professor, Center for Digestive Diseases
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
March 20, 2007
First Submitted That Met QC Criteria
March 20, 2007
First Posted (Estimate)
March 21, 2007
Study Record Updates
Last Update Posted (Estimate)
May 19, 2014
Last Update Submitted That Met QC Criteria
May 16, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Colitis, Microscopic
- Colitis
- Colitis, Collagenous
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Budesonide
- Mesalamine
Other Study ID Numbers
- BUC-60/COC
- 2006-004159-39
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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