check_circleStudy Completed
Irritable bowel syndrome
Bayer Identifier:
17063
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy/Safety study to confirm Iberogast's efficacy in patients with irritable bowel syndrome diagnosed on ROME III criteria compared to placebo
Trial purpose
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
243Trial Dates
October 2013 - October 2017Phase
Phase 3Could I Receive a placebo
YesProducts
Iberogast (STW5, BAY98-7411)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Berlin, 13086, Germany | |
Completed | Wardenburg, 26203, Germany | |
Completed | Marl, 45770, Germany | |
Completed | Hagen, 58095, Germany | |
Completed | Lollar, 35457, Germany | |
Withdrawn | Schwetzingen, 68723, Germany | |
Completed | Winsen, 21423, Germany | |
Completed | Ludwigshafen, 67067, Germany | |
Completed | Wiesbaden, 65185, Germany | |
Withdrawn | Recklinghausen, 45659, Germany | |
Completed | Potsdam, 14482, Germany | |
Completed | Berlin, 12157, Germany | |
Completed | Berlin, 13055, Germany | |
Withdrawn | Leverkusen, 51375, Germany | |
Completed | Mannheim, 68165, Germany | |
Completed | Essen, 45355, Germany | |
Completed | Halle, 06108, Germany | |
Completed | Blankenhain, 99444, Germany | |
Completed | Apolda, 99510, Germany | |
Withdrawn | Münster, 48159, Germany | |
Completed | Löhne, 32584, Germany | |
Completed | Sinzheim, 76547, Germany | |
Completed | Ludwigsburg, 71640, Germany | |
Withdrawn | Stockach, 78333, Germany | |
Completed | Essen, 45355, Germany | |
Withdrawn | Gauting, 82131, Germany | |
Completed | Reinfeld, 23858, Germany |
Primary Outcome
- Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatmentThe pain intensity is documented on a 10 cm visual analogue scale (VAS) scaledate_rangeTime Frame:28 days (+/- 3 days)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatmentdate_rangeTime Frame:14 days (+/- 3 days)enhanced_encryptionNoSafety Issue:
- Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scaledate_rangeTime Frame:28 days (+/- 3 days)enhanced_encryptionNoSafety Issue:
- Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)date_rangeTime Frame:28 days (+/- 3 days)
- Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baselinedate_rangeTime Frame:28 days (+/- 3 days)
- Numbers of participants with adverse events (AEs)date_rangeTime Frame:28 days (+/- 3 days)
- Vital signsblood pressure, heart rate, body weightdate_rangeTime Frame:28 days (+/- 3 days)
- Laboratory parametershaematology, blood chemistry, urinalysisdate_rangeTime Frame:28 days (+/- 3 days)
- Global assessment of tolerability on a 5-point Likert scale by Investigator and patientdate_rangeTime Frame:28 days (+/- 3 days)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2