Irritable Bowel Syndrome
Conditions
Keywords
Iberogast, efficacy, safety
Brief summary
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium pain
Interventions
DRUGSTW5 (Iberogast, BAY98-7411)
Applied orally over 28 days, 20 drops STW 5 three times daily
DRUGPlacebo
Applied orally over 28 days, 20 drops placebo three times daily
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| Vital signs | 28 days (+/- 3 days) | blood pressure, heart rate, body weight |
| 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) | — |
| Numbers of participants with adverse events (AEs) | 28 days (+/- 3 days) | — |
Countries
Germany
Outcome results
None listed