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Completed

NCT Number: NCT01940848

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

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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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ludwigsburg, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STW5 (Iberogast, BAY98-7411)

Drug

Applied orally over 28 days, 20 drops STW 5 three times daily

Placebo

Drug

Applied orally over 28 days, 20 drops placebo three times daily

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2013
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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