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

NCT02246686 | Terminated Phase 2

• 2 other identifiers: 171552013-000891-13
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 8

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.

Conditions

Colitis, Ulcerative

Keywords

Iberogast N; Mild to moderate ulcerative colitis; add-on therapy; efficacy

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

STW5-II

EXPERIMENTAL

Half of study population, assigned randomly

Drug: STW5-II (Iberogast N, BAY98-7410)

Placebo

PLACEBO COMPARATOR

Half of study population, assigned randomly

Drug: Placebo

Interventions

STW5-II (Iberogast N, BAY98-7410) DRUG

Application over 12 weeks 20 drops three time daily

STW5-II

Placebo DRUG

Application over 12 weeks 20 drops three time daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Unknown Facility

Dachau, Bavaria, 85221, Germany

Location

Unknown Facility

Hamburg, Hamburg, 20249, Germany

Location

Unknown Facility

Lüneburg, Lower Saxony, 21339, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Unknown Facility

Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany

Location

Unknown Facility

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Unknown Facility

Berlin, 14109, Germany

Location

Unknown Facility

Essen, 45276, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

DE (8)