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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Bayer Study Director; Bayer

More Information

• 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
• 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:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases