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

Bayer0 sites243 target enrollmentOctober 11, 2013

Overview

Phase: Phase 3
Intervention: STW5 (Iberogast, BAY98-7411)
Conditions: Irritable Bowel Syndrome
Sponsor: Bayer
Enrollment: 243
Primary Endpoint: Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
Status: Completed
Last Updated: 7 years ago

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

Registry

clinicaltrials.gov

Start Date

October 11, 2013

End Date

October 25, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

2/3 patients with irritable bowel syndrome will be randomized in this arm

Intervention: STW5 (Iberogast, BAY98-7411)

1/3 patients with irritable bowel syndrome will be randomized in this arm

Intervention: Placebo

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

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