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Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

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ClinicalTrials.gov Identifier: NCT02246686
Recruitment Status : Terminated
First Posted : September 23, 2014
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 19, 2014
First Posted Date  ICMJE September 23, 2014
Last Update Posted Date October 18, 2016
Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2014)
  • 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 (IBSS) at final visit [ Time Frame: From baseline to week 12 ]
  • Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit [ Time Frame: From baseline to week 12 ]
  • Mayo Score throughout the study [ Time Frame: Up to 12 weeks ]
  • Change of of oral mesalazine dose throughout the study period [ Time Frame: From baseline to week 12 ]
  • Change in ulcerative colitis (UC) markers [ Time Frame: From baseline to week 12 ]
    Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02246686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
Official Title  ICMJE 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
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colitis, Ulcerative
Intervention  ICMJE
  • Drug: STW5-II (Iberogast N, BAY98-7410)
    Application over 12 weeks 20 drops three time daily
  • Drug: Placebo
    Application over 12 weeks 20 drops three time daily
Study Arms  ICMJE
  • Experimental: STW5-II
    Half of study population, assigned randomly
    Intervention: Drug: STW5-II (Iberogast N, BAY98-7410)
  • Placebo Comparator: Placebo
    Half of study population, assigned randomly
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2014)
100
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246686
Other Study ID Numbers  ICMJE 17155
2013-000891-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP