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

This study has been completed.
Information provided by:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
First received: March 20, 2007
Last updated: June 21, 2012
Last verified: June 2012

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

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
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450086

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

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT00450086     History of Changes
Other Study ID Numbers: BUC-60/COC, 2006-004159-39
Study First Received: March 20, 2007
Last Updated: June 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 15, 2014