Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome
3 other identifiers
interventional
243
1 country
19
Brief Summary
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2013
Typical duration for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedStudy Start
First participant enrolled
October 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2017
CompletedOctober 29, 2018
October 1, 2018
4 years
September 9, 2013
October 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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)
Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
28 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)
- +3 more secondary outcomes
Study Arms (2)
STW5
EXPERIMENTAL2/3 patients with irritable bowel syndrome will be randomized in this arm
Placebo
PLACEBO COMPARATOR1/3 patients with irritable bowel syndrome will be randomized in this arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (19)
Unknown Facility
Ludwigsburg, Baden-Wurttemberg, 71640, Germany
Unknown Facility
Mannheim, Baden-Wurttemberg, 68165, Germany
Unknown Facility
Sinzheim, Baden-Wurttemberg, 76547, Germany
Unknown Facility
Potsdam, Brandenburg, 14482, Germany
Unknown Facility
Lollar, Hesse, 35457, Germany
Unknown Facility
Wiesbaden, Hesse, 65185, Germany
Unknown Facility
Wardenburg, Lower Saxony, 26203, Germany
Unknown Facility
Winsen, Lower Saxony, 21423, Germany
Unknown Facility
Essen, North Rhine-Westphalia, 45355, Germany
Unknown Facility
Hagen, North Rhine-Westphalia, 58095, Germany
Unknown Facility
Löhne, North Rhine-Westphalia, 32584, Germany
Unknown Facility
Marl, North Rhine-Westphalia, 45770, Germany
Unknown Facility
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany
Unknown Facility
Halle, Saxony-Anhalt, 06108, Germany
Unknown Facility
Reinfeld, Schleswig-Holstein, 23858, Germany
Unknown Facility
Apolda, Thuringia, 99510, Germany
Unknown Facility
Blankenhain, Thuringia, 99444, Germany
Unknown Facility
Berlin, 12157, Germany
Unknown Facility
Berlin, 13055, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2013
First Posted
September 12, 2013
Study Start
October 11, 2013
Primary Completion
October 25, 2017
Study Completion
October 25, 2017
Last Updated
October 29, 2018
Record last verified: 2018-10