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Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo

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ClinicalTrials.gov Identifier: NCT01940848
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: STW5 (Iberogast, BAY98-7411) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome
Actual Study Start Date : October 11, 2013
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

Arm Intervention/treatment
Experimental: STW5
2/3 patients with irritable bowel syndrome will be randomized in this arm
Drug: STW5 (Iberogast, BAY98-7411)
Applied orally over 28 days, 20 drops STW 5 three times daily

Placebo Comparator: Placebo
1/3 patients with irritable bowel syndrome will be randomized in this arm
Drug: Placebo
Applied orally over 28 days, 20 drops placebo three times daily




Primary Outcome Measures :
  1. Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment [ Time Frame: 28 days (+/- 3 days) ]
    The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale


Secondary Outcome Measures :
  1. Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment [ Time Frame: 14 days (+/- 3 days) ]
  2. Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale [ Time Frame: 28 days (+/- 3 days) ]
  3. Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale) [ Time Frame: 28 days (+/- 3 days) ]
  4. Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline [ Time Frame: 28 days (+/- 3 days) ]
  5. Numbers of participants with adverse events (AEs) [ Time Frame: 28 days (+/- 3 days) ]
  6. Vital signs [ Time Frame: 28 days (+/- 3 days) ]
    blood pressure, heart rate, body weight

  7. Laboratory parameters [ Time Frame: 28 days (+/- 3 days) ]
    haematology, blood chemistry, urinalysis

  8. Global assessment of tolerability on a 5-point Likert scale by Investigator and patient [ Time Frame: 28 days (+/- 3 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940848


Locations
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Germany
Ludwigsburg, Baden-Württemberg, Germany, 71640
Mannheim, Baden-Württemberg, Germany, 68165
Sinzheim, Baden-Württemberg, Germany, 76547
Potsdam, Brandenburg, Germany, 14482
Lollar, Hessen, Germany, 35457
Wiesbaden, Hessen, Germany, 65185
Wardenburg, Niedersachsen, Germany, 26203
Winsen, Niedersachsen, Germany, 21423
Essen, Nordrhein-Westfalen, Germany, 45355
Hagen, Nordrhein-Westfalen, Germany, 58095
Löhne, Nordrhein-Westfalen, Germany, 32584
Marl, Nordrhein-Westfalen, Germany, 45770
Ludwigshafen, Rheinland-Pfalz, Germany, 67067
Halle, Sachsen-Anhalt, Germany, 06108
Reinfeld, Schleswig-Holstein, Germany, 23858
Apolda, Thüringen, Germany, 99510
Blankenhain, Thüringen, Germany, 99444
Berlin, Germany, 12157
Berlin, Germany, 13055
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01940848     History of Changes
Other Study ID Numbers: 17063
STW5/212-D-011-III-V ( Other Identifier: Company internal )
2011-002613-10 ( EudraCT Number )
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Iberogast
efficacy
safety

Additional relevant MeSH terms:
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Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases