check_circleStudy 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
  • - 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

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
No

Where to participate

StatusInstitutionLocation
Withdrawn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Withdrawn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
    date_rangeTime Frame:
    28 days (+/- 3 days)
    enhanced_encryption
    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
    date_rangeTime Frame:
    14 days (+/- 3 days)
    enhanced_encryption
    Safety Issue:
    No
  • Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
    date_rangeTime Frame:
    28 days (+/- 3 days)
    enhanced_encryption
    Safety Issue:
    No
  • Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
    date_rangeTime Frame:
    28 days (+/- 3 days)
  • Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
    date_rangeTime Frame:
    28 days (+/- 3 days)
  • Numbers of participants with adverse events (AEs)
    date_rangeTime Frame:
    28 days (+/- 3 days)
  • Vital signs
    blood pressure, heart rate, body weight
    date_rangeTime Frame:
    28 days (+/- 3 days)
  • Laboratory parameters
    haematology, blood chemistry, urinalysis
    date_rangeTime Frame:
    28 days (+/- 3 days)
  • Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
    date_rangeTime 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
2

Additional Information

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