Clinical Trial: Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic Colitis

Brief Summary: The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.

Detailed Summary: N.A.
Sponsor: Dr. Falk Pharma GmbH

Current Primary Outcome: Rate of clinical remission [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of clinical remission [ Time Frame: 2 weeks ]
  • Rate of clinical remission [ Time Frame: 6 weeks ]
  • Time to remission [ Time Frame: 8 weeks ]
  • Number of formed/soft/watery stools per week [ Time Frame: 8 weeks ]
  • Number of days with abdominal pain [ Time Frame: 8 weeks ]
  • Number of days with urgency [ Time Frame: 8 weeks ]
  • Rate of histological remission [ Time Frame: 8 weeks ]
  • Physician's global assessment at final visit [ Time Frame: 8 weeks ]
  • Quality of life [ Time Frame: 8 weeks ]


Original Secondary Outcome:

  • Rate of clinical remission [ Time Frame: 2 weeks ]
  • Rate of clinical remission [ Time Frame: 6 weeks ]
  • Time to remission [ Time Frame: N.A. ]
  • Number of formed/soft/watery stools per week [ Time Frame: 8 weeks ]
  • Number of days with abdominal pain [ Time Frame: 8 weeks ]
  • Number of days with urgency [ Time Frame: 8 weeks ]
  • Rate of histological remission [ Time Frame: 8 weeks ]
  • Physician's global assessment at final visit [ Time Frame: 8 weeks ]
  • Quality of life [ Time Frame: 8 weeks ]


Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: May 14, 2014
Date Started: May 2014
Date Completion: July 2018
Last Updated: February 2, 2017
Last Verified: February 2017