Trial Condition(s):
Efficacy/Safety study to confirm Iberogast's efficacy in patients with irritable bowel syndrome diagnosed on ROME III criteria compared to placebo
17063
Not Available
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"
- 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
- 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
Locations | Status | |
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Locations Investigative Site Wardenburg, Germany, 26203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Marl, Germany, 45770 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hagen, Germany, 58095 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lollar, Germany, 35457 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Winsen, Germany, 21423 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ludwigshafen, Germany, 67067 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Wiesbaden, Germany, 65185 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Potsdam, Germany, 14482 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Berlin, Germany, 12157 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Berlin, Germany, 13055 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Mannheim, Germany, 68165 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Essen, Germany, 45355 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Halle, Germany, 06108 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Blankenhain, Germany, 99444 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Apolda, Germany, 99510 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Löhne, Germany, 32584 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sinzheim, Germany, 76547 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ludwigsburg, Germany, 71640 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Reinfeld, Germany, 23858 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
A double-blind, randomised, placebo-controlled study on the efficacy of Iberogast® (STW5) in patients with irritable bowel syndrome
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2