Clinical Trial: Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Patien

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

Detailed Summary: 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.
Sponsor: Dr. Falk Pharma GmbH

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

Original Primary Outcome: Rate of clinical remission (<= 3 stools per day) after 8 weeks

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Rate of clinical remission (<= 3 stools per day) after 2 weeks
  • Time to remission
  • Impact on stool consistency (watery/soft/solid)
  • Impact on abdominal pain
  • Impact on patient's general well-being
  • Effect on histopathology
  • Severity of diarrhea
  • QoL
  • PGA


Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: March 20, 2007
Date Started: March 2007
Date Completion:
Last Updated: May 16, 2014
Last Verified: May 2014