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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02246686
• Other study ID #: 17155
• Secondary ID: 2013-000891-13
• Status: Terminated
• Phase: Phase 2
• First received: September 19, 2014
• Last updated: October 17, 2016
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• STW5-II (Iberogast N, BAY98-7410)
Application over 12 weeks 20 drops three time daily
• Placebo
Application over 12 weeks 20 drops three time daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients being in remission at final visit	Responder definition for remission: Clinical Activity Index (CAI) = 4	Week 12	No
Primary	Change of endoscopic index (EI)		From baseline to week 12	No
Primary	Change of histological index (HI) based on Riley		From baseline to week 12	No
Primary	Proportion of patients reaching a clinical CAI = 2 points		Week 12	No
Primary	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	No
Primary	Time to sustained remission (CAI = 2 points) defined as days from Day 0 until first sustained remission is reached		Up to 12 weeks	No
Primary	Number of patients who reached a remission at least once during the course of the study		Week 12	No
Primary	Number of patients who reached a sustained remission at least once during the course of the study		Week 12	No
Primary	Change from baseline of absolute CAI values to final visit		From baseline to week 12	No
Primary	Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit		From baseline to week 12	No
Primary	Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit		From baseline to week 12	No
Primary	Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit		From baseline to week 12	No
Primary	Mayo Score throughout the study		Up to 12 weeks	No
Primary	Change of of oral mesalazine dose throughout the study period		From baseline to week 12	No
Primary	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	No

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