Back to resultsEfficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
STW5 (Iberogast, BAY98-7411)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Iberogast, efficacy, safety
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
STW5
Placebo
Arm Description
2/3 patients with irritable bowel syndrome will be randomized in this arm
1/3 patients with irritable bowel syndrome will be randomized in this arm
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
Numbers of participants with adverse events (AEs)
Vital signs
blood pressure, heart rate, body weight
Laboratory parameters
haematology, blood chemistry, urinalysis
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01940848
Brief Title
Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
Official Title
A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 11, 2013 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Iberogast, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
243 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STW5
Arm Type
Experimental
Arm Description
2/3 patients with irritable bowel syndrome will be randomized in this arm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1/3 patients with irritable bowel syndrome will be randomized in this arm
Intervention Type
Drug
Intervention Name(s)
STW5 (Iberogast, BAY98-7411)
Intervention Description
Applied orally over 28 days, 20 drops STW 5 three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Applied orally over 28 days, 20 drops placebo three times daily
Primary Outcome Measure Information:
Title
Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
Description
The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale
Time Frame
28 days (+/- 3 days)
Secondary Outcome Measure Information:
Title
Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
Time Frame
14 days (+/- 3 days)
Title
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
Time Frame
28 days (+/- 3 days)
Title
Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
Time Frame
28 days (+/- 3 days)
Title
Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
Time Frame
28 days (+/- 3 days)
Title
Numbers of participants with adverse events (AEs)
Time Frame
28 days (+/- 3 days)
Title
Vital signs
Description
blood pressure, heart rate, body weight
Time Frame
28 days (+/- 3 days)
Title
Laboratory parameters
Description
haematology, blood chemistry, urinalysis
Time Frame
28 days (+/- 3 days)
Title
Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
Time Frame
28 days (+/- 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Ludwigsburg
State/Province
Baden-Württemberg
ZIP/Postal Code
71640
Country
Germany
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68165
Country
Germany
City
Sinzheim
State/Province
Baden-Württemberg
ZIP/Postal Code
76547
Country
Germany
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14482
Country
Germany
City
Lollar
State/Province
Hessen
ZIP/Postal Code
35457
Country
Germany
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65185
Country
Germany
City
Wardenburg
State/Province
Niedersachsen
ZIP/Postal Code
26203
Country
Germany
City
Winsen
State/Province
Niedersachsen
ZIP/Postal Code
21423
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
City
Hagen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58095
Country
Germany
City
Löhne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32584
Country
Germany
City
Marl
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45770
Country
Germany
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67067
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06108
Country
Germany
City
Reinfeld
State/Province
Schleswig-Holstein
ZIP/Postal Code
23858
Country
Germany
City
Apolda
State/Province
Thüringen
ZIP/Postal Code
99510
Country
Germany
City
Blankenhain
State/Province
Thüringen
ZIP/Postal Code
99444
Country
Germany
City
Berlin
ZIP/Postal Code
12157
Country
Germany
City
Berlin
ZIP/Postal Code
13055
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.
Learn more about this trial
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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