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 ]
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