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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450086
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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

Condition or disease Intervention/treatment Phase
Collagenous Colitis Drug: Budesonide Drug: Mesalazine Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Budesonide
9 mg per day
Experimental: B Drug: Mesalazine
3 g per day
Placebo Comparator: C Drug: Placebo
0 g per day

Primary Outcome Measures :
  1. Rate of clinical remission (<= 3 stools per day) after 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Rate of clinical remission (<= 3 stools per day) after 2 weeks [ Time Frame: 2 weeks ]
  2. Time to remission
  3. Impact on stool consistency (watery/soft/solid) [ Time Frame: 8 weeks ]
  4. Impact on abdominal pain [ Time Frame: 8 weeks ]
  5. Impact on patient's general well-being [ Time Frame: 8 weeks ]
  6. Effect on histopathology [ Time Frame: 8 weeks ]
  7. Severity of diarrhea [ Time Frame: 8 weeks ]
  8. QoL [ Time Frame: 8 weeks ]
  9. PGA [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00450086

Center of digestive diseases
Hamburg, Germany, 20249
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Stephan Miehlke, Professor Center for digestive diseases

Publications of Results:
Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00450086     History of Changes
Other Study ID Numbers: BUC-60/COC
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Colitis, Collagenous
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Colitis, Microscopic
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents