Clinical trial NCT01940848: Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
Official title: A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Iberogast
efficacy
safety
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment
timeFrame: 28 days (+/- 3 days)
Secondary outcomes:
measure: Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment
timeFrame: 14 days (+/- 3 days)
measure: Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale
timeFrame: 28 days (+/- 3 days)
measure: Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale)
timeFrame: 28 days (+/- 3 days)
measure: Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline
timeFrame: 28 days (+/- 3 days)
measure: Numbers of participants with adverse events (AEs)
timeFrame: 28 days (+/- 3 days)
measure: Vital signs
timeFrame: 28 days (+/- 3 days)
measure: Laboratory parameters
timeFrame: 28 days (+/- 3 days)
measure: Global assessment of tolerability on a 5-point Likert scale by Investigator and patient
timeFrame: 28 days (+/- 3 days)
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
state: Baden-Württemberg
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Sinzheim
country: Germany
state: Baden-Württemberg
city: Potsdam
country: Germany
state: Brandenburg
city: Lollar
country: Germany
state: Hessen
city: Wiesbaden
country: Germany
state: Hessen
city: Wardenburg
country: Germany
state: Niedersachsen
city: Winsen
country: Germany
state: Niedersachsen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Hagen
country: Germany
state: Nordrhein-Westfalen
city: Löhne
country: Germany
state: Nordrhein-Westfalen
city: Marl
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Reinfeld
country: Germany
state: Schleswig-Holstein
city: Apolda
country: Germany
state: Thüringen
city: Blankenhain
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: