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

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Bayer

Status and phase

Completed
Phase 3

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Placebo
Drug: STW5 (Iberogast, BAY98-7411)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01940848
17063
2011-002613-10 (EudraCT Number)
STW5/212-D-011-III-V (Other Identifier)

Details and patient eligibility

About

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

Enrollment

243 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

243 participants in 2 patient groups, including a placebo group

STW5
Experimental group
Description:
2/3 patients with irritable bowel syndrome will be randomized in this arm
Treatment:
Drug: STW5 (Iberogast, BAY98-7411)
Placebo
Placebo Comparator group
Description:
1/3 patients with irritable bowel syndrome will be randomized in this arm
Treatment:
Drug: Placebo

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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