stop_circleTerminated/Withdrawn

Colitis, Ulcerative

Bayer Identifier:

17155

ClinicalTrials.gov Identifier:

NCT02246686

EudraCT Number:

2013-000891-13

EU CT Number:

Not Available
Efficacy/Safety pilot study to investigate Iberogast N's efficacy in mild to moderate colitis ulcerosa patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 80 Years
  • - Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
    - Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
    - Age between 18 to 80 years (including)
    - UC may reach from left-sided colitis to pancolitis
  • - Severe forms of UC (CAI > 10)
    - Crohn's disease, infectious colitis or undetermined colitis
    - Steroid dependence and steroid resistance
    - Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
    - Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
    - Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
    - Total colectomy
    - Known allergies to components of STW5-II
    - Severe allergic diathesis
    - Topical mesalazine application
    - Known intolerance to azo dyes E110 and E151

Trial summary

Enrollment Goal
3
Trial Dates
November 2014 - April 2016
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Iberogast N (STW5-II, BAY98-7410)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Essen, 45276, Germany
Terminated
Berlin, 14109, Germany
Terminated
Ludwigshafen, 67067, Germany
Completed
Dachau, 85221, Germany
Terminated
Köln, 50937, Germany
Terminated
Lübeck, 23538, Germany
Terminated
Lüneburg, 21339, Germany
Terminated
Hamburg, 20249, Germany

Primary Outcome

  • Proportion of patients being in remission at final visit
    Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change of endoscopic index (EI)
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change of histological index (HI) based on Riley
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients reaching a clinical CAI ≤ 2 points
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Time to remission, defined as days from Day 0 until first remission is reached
    Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients who reached a remission at least once during the course of the study
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients who reached a sustained remission at least once during the course of the study
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline of absolute CAI values to final visit
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Mayo Score throughout the study
    date_rangeTime Frame:
    Up to 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Change of of oral mesalazine dose throughout the study period
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No
  • Change in ulcerative colitis (UC) markers
    Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
    date_rangeTime Frame:
    From baseline to week 12
    enhanced_encryption
    Safety Issue:
    No

Trial design

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 moderate ulcerative colitis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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