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

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

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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