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