Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: March 20, 2007
Last updated: May 16, 2014
Last verified: May 2014
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 ]

Enrollment: 92
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00450086     History of Changes
Other Study ID Numbers: BUC-60/COC  2006-004159-39 
Study First Received: March 20, 2007
Last Updated: May 16, 2014
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on October 26, 2016