Study Completed

Irritable bowel syndrome

Bayer Identifier:

17063

ClinicalTrials.gov Identifier:

NCT01940848

EudraCT Number:

2011-002613-10

EU CT Number:

Not Available

Efficacy/Safety study to confirm Iberogast's efficacy in patients with irritable bowel syndrome diagnosed on ROME III criteria compared to placebo

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A

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

Trial summary

Enrollment Goal

243

Trial Dates

October 2013 - October 2017

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Iberogast (STW5, BAY98-7411)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn		Berlin, 13086, Germany
Completed		Wardenburg, 26203, Germany
Completed		Marl, 45770, Germany
Completed		Hagen, 58095, Germany
Completed		Lollar, 35457, Germany
Withdrawn		Schwetzingen, 68723, Germany
Completed		Winsen, 21423, Germany
Completed		Ludwigshafen, 67067, Germany
Completed		Wiesbaden, 65185, Germany
Withdrawn		Recklinghausen, 45659, Germany
Completed		Potsdam, 14482, Germany
Completed		Berlin, 12157, Germany
Completed		Berlin, 13055, Germany
Withdrawn		Leverkusen, 51375, Germany
Completed		Mannheim, 68165, Germany
Completed		Essen, 45355, Germany
Completed		Halle, 06108, Germany
Completed		Blankenhain, 99444, Germany
Completed		Apolda, 99510, Germany
Withdrawn		Münster, 48159, Germany
Completed		Löhne, 32584, Germany
Completed		Sinzheim, 76547, Germany
Completed		Ludwigsburg, 71640, Germany
Withdrawn		Stockach, 78333, Germany
Completed		Essen, 45355, Germany
Withdrawn		Gauting, 82131, Germany
Completed		Reinfeld, 23858, Germany

Primary Outcome

Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale
Time Frame:
28 days (+/- 3 days)
Safety Issue:
No

Secondary Outcome

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)
Safety Issue:
No
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
Time Frame:
28 days (+/- 3 days)
Safety Issue:
No
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
Time Frame:
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)
Numbers of participants with adverse events (AEs)
Time Frame:
28 days (+/- 3 days)
Vital signs
blood pressure, heart rate, body weight
Time Frame:
28 days (+/- 3 days)
Laboratory parameters
haematology, blood chemistry, urinalysis
Time Frame:
28 days (+/- 3 days)
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
Time Frame:
28 days (+/- 3 days)

Trial design

A double-blind, randomised, placebo-controlled study on the efficacy of Iberogast® (STW5) in patients with irritable bowel syndrome

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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