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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: STW5-II (Iberogast N, BAY98-7410); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
  • Essen, Germany, 45276
  • Hamburg, Germany, 20249
  • Bayern
    • Dachau, Bayern, Germany, 85221
  • Niedersachsen
    • Lüneburg, Niedersachsen, Germany, 21339
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67067
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients being in remission at final visit	Responder definition for remission: Clinical Activity Index (CAI) ≤ 4	Week 12
Change of endoscopic index (EI)		From baseline to week 12
Change of histological index (HI) based on Riley		From baseline to week 12
Proportion of patients reaching a clinical CAI ≤ 2 points		Week 12
Time to remission, defined as days from Day 0 until first remission is reached	Responder definition for remission: Clinical Activity Index (CAI) ≤ 4	Up to 12 weeks
Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached		Up to 12 weeks
Number of patients who reached a remission at least once during the course of the study		Week 12
Number of patients who reached a sustained remission at least once during the course of the study		Week 12
Change from baseline of absolute CAI values to final visit		From baseline to week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit		From baseline to week 12
Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit		From baseline to week 12
Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit		From baseline to week 12
Mayo Score throughout the study		Up to 12 weeks
Change of of oral mesalazine dose throughout the study period		From baseline to week 12
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	From baseline to week 12

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 19, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: efficacy; Iberogast N; Mild to moderate ulcerative colitis; add-on therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 17155; 2013-000891-13 (EudraCT Number)