Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo

October 26, 2018 updated by: Bayer

A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome

The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

243

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13055
      • Berlin, Germany, 12157
    • Baden-Württemberg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
      • Mannheim, Baden-Württemberg, Germany, 68165
      • Sinzheim, Baden-Württemberg, Germany, 76547
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14482
    • Hessen
      • Lollar, Hessen, Germany, 35457
      • Wiesbaden, Hessen, Germany, 65185
    • Niedersachsen
      • Wardenburg, Niedersachsen, Germany, 26203
      • Winsen, Niedersachsen, Germany, 21423
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45355
      • Hagen, Nordrhein-Westfalen, Germany, 58095
      • Löhne, Nordrhein-Westfalen, Germany, 32584
      • Marl, Nordrhein-Westfalen, Germany, 45770
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67067
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06108
    • Schleswig-Holstein
      • Reinfeld, Schleswig-Holstein, Germany, 23858
    • Thüringen
      • Apolda, Thüringen, Germany, 99510
      • Blankenhain, Thüringen, Germany, 99444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of either sex aged >18 years

  • Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following:

    • Improvement with defecation
    • Onset associated with a change in frequency of stool
    • Onset associated with a change in form (appearance) of stool
  • History of pain intensity with an average of worst abdominal pain in past 24 hours score of > 30 on a daily measured VAS (visual analogue scale) during screening phase

Exclusion Criteria:

  • Intake of STW5 within the last 5 years
  • Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function
  • Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)
  • Patients with known hypersensitivity to any component of the trial drugs
  • History of eating disorders
  • Patients with a history of diseases with abdominal symptoms that can resemble IBS
  • Presence of any other acute or chronic gastrointestinal disorder
  • History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)
  • Known intolerance to azo dyes E 110 and E 151

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STW5
2/3 patients with irritable bowel syndrome will be randomized in this arm
Drug: STW5 (Iberogast, BAY98-7411)
Applied orally over 28 days, 20 drops STW 5 three times daily
Placebo Comparator: Placebo
1/3 patients with irritable bowel syndrome will be randomized in this arm
Drug: Placebo
Applied orally over 28 days, 20 drops placebo three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
Time Frame: 28 days (+/- 3 days)
The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale
28 days (+/- 3 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
Time Frame: 14 days (+/- 3 days)
14 days (+/- 3 days)
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
Time Frame: 28 days (+/- 3 days)
28 days (+/- 3 days)
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
Time Frame: 28 days (+/- 3 days)
28 days (+/- 3 days)
Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
Time Frame: 28 days (+/- 3 days)
28 days (+/- 3 days)
Numbers of participants with adverse events (AEs)
Time Frame: 28 days (+/- 3 days)
28 days (+/- 3 days)
Vital signs
Time Frame: 28 days (+/- 3 days)
blood pressure, heart rate, body weight
28 days (+/- 3 days)
Laboratory parameters
Time Frame: 28 days (+/- 3 days)
haematology, blood chemistry, urinalysis
28 days (+/- 3 days)
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
Time Frame: 28 days (+/- 3 days)
28 days (+/- 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2013

Primary Completion (Actual)

October 25, 2017

Study Completion (Actual)

October 25, 2017

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17063
  • STW5/212-D-011-III-V (Other Identifier: Company internal)
  • 2011-002613-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on STW5 (Iberogast, BAY98-7411)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe