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

Irritable Bowel Syndrome Clinical Trial

Official title:

A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940848
• Other study ID #: 17063
• Secondary ID: STW5/212-D-011-I
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2013
• Est. completion date: October 25, 2017

Study information

• Verified date: October 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• STW5 (Iberogast, BAY98-7411)
Applied orally over 28 days, 20 drops STW 5 three times daily
• Placebo
Applied orally over 28 days, 20 drops placebo three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days (+/- 3 days)
Secondary	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)
Secondary	Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale		28 days (+/- 3 days)
Secondary	Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)		28 days (+/- 3 days)
Secondary	Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline		28 days (+/- 3 days)
Secondary	Numbers of participants with adverse events (AEs)		28 days (+/- 3 days)
Secondary	Vital signs	blood pressure, heart rate, body weight	28 days (+/- 3 days)
Secondary	Laboratory parameters	haematology, blood chemistry, urinalysis	28 days (+/- 3 days)
Secondary	Global assessment of tolerability on a 5-point Likert scale by Investigator and patient		28 days (+/- 3 days)

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