Clinical Trial: Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

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

Official Title: Randomized, Double-blind, Multicentre Study to Compare the Efficacy and Safety of Budesonide Versus Mesalazine Suppository Versus a Combination Therapy of Budesonide/Mesalazine Suppositories in Patien

Brief Summary: The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.

Detailed Summary:
Sponsor: Dr. Falk Pharma GmbH

Current Primary Outcome: Resolution of clinical symptoms [ Time Frame: 8 weeks ]

Symptoms as reported in the diary


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of clinical and endoscopic remission [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary, ulcerative colitis-disease activity index
  • Rate of improvement [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary, ulcerative colitis-disease activity index
  • Rate of patients with clinical remission [ Time Frame: 8 weeks ]
    Symptoms as reported in the diary, ulcerative colitis-disease activity index
  • Rate of patients with endoscopic remission [ Time Frame: 8 weeks ]
    Ulcerative colitis-disease activity index


Original Secondary Outcome: Same as current

Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: October 9, 2013
Date Started: September 2013
Date Completion:
Last Updated: January 20, 2016
Last Verified: January 2016