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

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: STW5 (Iberogast, BAY98-7411)

• Registration Number: NCT01940848
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Study Start: 2013-10-11
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1/3 patients with irritable bowel syndrome will be randomized in this arm
STW5	STW5 (Iberogast, BAY98-7411)	2/3 patients with irritable bowel syndrome will be randomized in this arm

Primary Outcome Measures

Name	Time	Method
Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment	28 days (+/- 3 days)	The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale

Secondary Outcome Measures

Name	Time	Method
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)	haematology, blood chemistry, urinalysis
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient	28 days (+/- 3 days)
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale	28 days (+/- 3 days)
Vital signs	28 days (+/- 3 days)	blood pressure, heart rate, body weight