Clinical Trial: Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderat
Brief Summary: The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome:
- Proportion of patients being in remission at final visit [ Time Frame: Week 12 ]Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
- Change of endoscopic index (EI) [ Time Frame: From baseline to week 12 ]
- Change of histological index (HI) based on Riley [ Time Frame: From baseline to week 12 ]
- Proportion of patients reaching a clinical CAI ≤ 2 points [ Time Frame: Week 12 ]
- Time to remission, defined as days from Day 0 until first remission is reached [ Time Frame: Up to 12 weeks ]Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
- Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached [ Time Frame: Up to 12 weeks ]
- Number of patients who reached a remission at least once during the course of the study [ Time Frame: Week 12 ]
- Number of patients who reached a sustained remission at least once during the course of the study [ Time Frame: Week 12 ]
- Change from baseline of absolute CAI values to final visit [ Time Frame: From baseline to week 12 ]
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit [ Time Frame: From baseline to week 12 ]
- Change from baseline in Irritable Bowel Severity Score (IBS
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bayer
Dates:
Date Received: September 19, 2014
Date Started: November 2014
Date Completion:
Last Updated: October 17, 2016
Last Verified: October 2016