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| ID | Type | Description | Link |
|---|---|---|---|
| STW5/212-D-011-III-V | Other Identifier | Company internal | |
| 2011-002613-10 | EudraCT Number |
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The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STW5 | Experimental | 2/3 patients with irritable bowel syndrome will be randomized in this arm |
|
| Placebo | Placebo Comparator | 1/3 patients with irritable bowel syndrome will be randomized in this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STW5 (Iberogast, BAY98-7411) | Drug | Applied orally over 28 days, 20 drops STW 5 three times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwigsburg | Baden-Wurttemberg | 71640 | Germany | |||
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| Placebo |
| Drug |
Applied orally over 28 days, 20 drops placebo three times daily |
|
| 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) |
| Vital signs | blood pressure, heart rate, body weight | 28 days (+/- 3 days) |
| Laboratory parameters | haematology, blood chemistry, urinalysis | 28 days (+/- 3 days) |
| Global assessment of tolerability on a 5-point Likert scale by Investigator and patient | 28 days (+/- 3 days) |
| Mannheim |
| Baden-Wurttemberg |
| 68165 |
| Germany |
| Sinzheim | Baden-Wurttemberg | 76547 | Germany |
| Potsdam | Brandenburg | 14482 | Germany |
| Lollar | Hesse | 35457 | Germany |
| Wiesbaden | Hesse | 65185 | Germany |
| Wardenburg | Lower Saxony | 26203 | Germany |
| Winsen | Lower Saxony | 21423 | Germany |
| Essen | North Rhine-Westphalia | 45355 | Germany |
| Hagen | North Rhine-Westphalia | 58095 | Germany |
| Löhne | North Rhine-Westphalia | 32584 | Germany |
| Marl | North Rhine-Westphalia | 45770 | Germany |
| Ludwigshafen am Rhein | Rhineland-Palatinate | 67067 | Germany |
| Halle | Saxony-Anhalt | 06108 | Germany |
| Reinfeld | Schleswig-Holstein | 23858 | Germany |
| Apolda | Thuringia | 99510 | Germany |
| Blankenhain | Thuringia | 99444 | Germany |
| Berlin | 12157 | Germany |
| Berlin | 13055 | Germany |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C039964 | iberogast |
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