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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

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: STW5-II (Iberogast N, BAY98-7410) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Moderate Ulcerative Colitis
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STW5-II
Half of study population, assigned randomly
Drug: STW5-II (Iberogast N, BAY98-7410)
Application over 12 weeks 20 drops three time daily

Placebo Comparator: Placebo
Half of study population, assigned randomly
Drug: Placebo
Application over 12 weeks 20 drops three time daily




Primary Outcome Measures :
  1. Proportion of patients being in remission at final visit [ Time Frame: Week 12 ]
    Responder definition for remission: Clinical Activity Index (CAI) ≤ 4

  2. Change of endoscopic index (EI) [ Time Frame: From baseline to week 12 ]
  3. Change of histological index (HI) based on Riley [ Time Frame: From baseline to week 12 ]
  4. Proportion of patients reaching a clinical CAI ≤ 2 points [ Time Frame: Week 12 ]
  5. 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

  6. 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 ]
  7. Number of patients who reached a remission at least once during the course of the study [ Time Frame: Week 12 ]
  8. Number of patients who reached a sustained remission at least once during the course of the study [ Time Frame: Week 12 ]
  9. Change from baseline of absolute CAI values to final visit [ Time Frame: From baseline to week 12 ]
  10. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit [ Time Frame: From baseline to week 12 ]
  11. Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit [ Time Frame: From baseline to week 12 ]
  12. Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit [ Time Frame: From baseline to week 12 ]
  13. Mayo Score throughout the study [ Time Frame: Up to 12 weeks ]
  14. Change of of oral mesalazine dose throughout the study period [ Time Frame: From baseline to week 12 ]
  15. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246686


Locations
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Germany
Dachau, Bayern, Germany, 85221
Lüneburg, Niedersachsen, Germany, 21339
Köln, Nordrhein-Westfalen, Germany, 50937
Ludwigshafen, Rheinland-Pfalz, Germany, 67067
Lübeck, Schleswig-Holstein, Germany, 23538
Berlin, Germany, 14109
Essen, Germany, 45276
Hamburg, Germany, 20249
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02246686     History of Changes
Other Study ID Numbers: 17155
2013-000891-13 ( EudraCT Number )
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Bayer:
Iberogast N
Mild to moderate ulcerative colitis
add-on therapy
efficacy
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases