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

Primary Purpose

Colitis, Ulcerative

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

STW5-II (Iberogast N, BAY98-7410)

Placebo

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Iberogast N, Mild to moderate ulcerative colitis, add-on therapy, efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

STW5-II

Placebo

Arm Description

Half of study population, assigned randomly

Outcomes

Primary Outcome Measures

Proportion of patients being in remission at final visit

Responder definition for remission: Clinical Activity Index (CAI) ≤ 4

Change of endoscopic index (EI)

Change of histological index (HI) based on Riley

Proportion of patients reaching a clinical CAI ≤ 2 points

Time to remission, defined as days from Day 0 until first remission is reached

Responder definition for remission: Clinical Activity Index (CAI) ≤ 4

Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached

Number of patients who reached a remission at least once during the course of the study

Number of patients who reached a sustained remission at least once during the course of the study

Change from baseline of absolute CAI values to final visit

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit

Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit

Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit

Mayo Score throughout the study

Change of of oral mesalazine dose throughout the study period

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02246686

First Posted

September 19, 2014

Last Updated

October 17, 2016

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02246686

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Study Start Date

November 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colitis, Ulcerative

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STW5-II

Arm Type

Experimental

Arm Description

Half of study population, assigned randomly

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Half of study population, assigned randomly

Intervention Type

Drug

Intervention Name(s)

STW5-II (Iberogast N, BAY98-7410)

Intervention Description

Application over 12 weeks 20 drops three time daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Application over 12 weeks 20 drops three time daily

Primary Outcome Measure Information:

Title

Proportion of patients being in remission at final visit

Description

Responder definition for remission: Clinical Activity Index (CAI) ≤ 4

Time Frame

Week 12

Title

Change of endoscopic index (EI)

Time Frame

From baseline to week 12

Title

Change of histological index (HI) based on Riley

Time Frame

From baseline to week 12

Title

Proportion of patients reaching a clinical CAI ≤ 2 points

Time Frame

Week 12

Title

Time to remission, defined as days from Day 0 until first remission is reached

Description

Responder definition for remission: Clinical Activity Index (CAI) ≤ 4

Time Frame

Up to 12 weeks

Title

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

Title

Number of patients who reached a remission at least once during the course of the study

Time Frame

Week 12

Title

Number of patients who reached a sustained remission at least once during the course of the study

Time Frame

Week 12

Title

Change from baseline of absolute CAI values to final visit

Time Frame

From baseline to week 12

Title

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit

Time Frame

From baseline to week 12

Title

Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit

Time Frame

From baseline to week 12

Title

Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit

Time Frame

From baseline to week 12

Title

Mayo Score throughout the study

Time Frame

Up to 12 weeks

Title

Change of of oral mesalazine dose throughout the study period

Time Frame

From baseline to week 12

Title

Change in ulcerative colitis (UC) markers

Description

Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients

Time Frame

From baseline to week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Dachau

State/Province

Bayern

ZIP/Postal Code

85221

Country

Germany

City

Lüneburg

State/Province

Niedersachsen

ZIP/Postal Code

21339

Country

Germany

City

Köln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

City

Ludwigshafen

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67067

Country

Germany

City

Lübeck

State/Province

Schleswig-Holstein

ZIP/Postal Code

23538

Country

Germany

City

Berlin

ZIP/Postal Code

14109

Country

Germany

City

Essen

ZIP/Postal Code

45276

Country

Germany

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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