A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW 5) in Patients With Functional Dyspepsia and Concomitant Reflux Symptoms Measured With Impedance and Wireless pH Monitoring

Bayer1 site in 1 country64 target enrollmentJune 18, 2009

ConditionsFunctional Gastrointestinal Disorders

InterventionsSTW5 (Iberogast®, BAY98-7411)Placebo

DrugsSTW5 (Iberogast®, BAY98-7411)Placebo

Overview

Phase: Phase 2
Intervention: STW5 (Iberogast®, BAY98-7411)
Conditions: Functional Gastrointestinal Disorders
Sponsor: Bayer
Enrollment: 64
Locations: 1
Primary Endpoint: AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this study researchers want to learn more about the effectiveness of Iberogast® in patients with irritable stomach and concomitant chronic or recurrent heartburn and backward flow of stomach liquid into the esophagus. 60 patients in the age range from 18 - 80 year will be treated over 4 weeks with Iberogast® or placebo - an inactive substance which looks identical to Iberogast®. Patients completed diaries will provide researchers with detailed information on the change of stomach and intestinal symptoms during the treatment period. In addition information on the acidity of the esophagus and stomach liquid will be collected.

Registry

clinicaltrials.gov

Start Date

June 18, 2009

End Date

May 3, 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of either sex aged 18-80 years.
•Diagnosis of functional dyspepsia according to Rome III criteria:
•Pain or burning localized to the epigastrium of at least moderate severity at least once per week with a total duration of at least 6 months.
•Pain was intermittent.
•Pain was not generalized or localized to other abdominal or chest regions.
•Pain was not relieved by defecation or passage of flatus.
•Pain did not fulfil criteria for gallbladder and sphincter of Oddi disorders.
•At assessment (visit 1 or 3) three items of GIS had to be judged at least as moderate including reflux symptoms, but reflux symptoms not dominating the clinical picture.
•Endoscopy of the upper gastrointestinal tract and abdominal sonography without pathological findings that could have explained the symptoms (findings of up to 5 gastric erosions could be tolerated if patient had no concomitant intake of acetylsalicylic acid).
•Patients willing to comply with the study protocol.

Exclusion Criteria

•Concomitant treatment during the study with any medication that could influence the gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant, laxatives, calcium antagonists, beta-blocker, antidiarrheics).
•Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2 (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
•History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer.
•History of gastric and/or duodenal ulcer.
•History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
•History and/or presence of coronary heart disease.
•Known intolerance to azo dyes E 110 and E
•Food allergies and known lactose intolerance.
•Evidence of any gastrointestinal infectious diseases.
•Participation in a clinical trial 30 days prior to this trial.

Arms & Interventions

STW5 (Iberogast®, BAY98-7411)

The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.

Intervention: STW5 (Iberogast®, BAY98-7411)

Placebo

The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals

Intervention: Placebo

Outcomes

Primary Outcomes

AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale.

Time Frame: Up to 28 days

Area under the curve (AUC) of patients' assessment of gastrointestinal symptoms evaluated by daily visual analogue scale (VAS)

Secondary Outcomes

Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the end of study (day 28)(At baseline and day 28)
AUC of reflux symptoms assessment measured by daily VAS scale(Up to 28 days)
Quality of Life evaluation as assessed by Functional Dyspepsia Quality of Life (FDDQL)(At baseline and day 28)
Relative time with an esophageal pH < 4 during 24 hours of measurement by Bravo™ pH system(At day -7/ -5 (screening phase) and day 29/30 if applicable)
Relative time with an esophageal pH < 4 during 24 hours of measurement using intraluminal impedance(At day -1 (screening phase) and day 29/30 if applicable)
Calculation of the DeMeester Score measured based on Bravo™ pH system(At day -7/ -5 (screening phase) and day 29/30 if applicable)
System index measurement in parallel to the pH measurement by Bravo™ pH system(At day -7/ -5 (screening phase) and day 29/30 if applicable)
Calculation of the DeMeester Score based on intraluminal impedance(At day -1 (screening phase) and day 29/30 if applicable)
Global Subject Outcome Assessment at visit 5(At day 28 (visit 5))
Bolus exposition time in minutes and as percentual part of measurement time for acid reflux, non-acid reflux and total (acid and non-acid) reflux using intraluminal impedance(At day -1 (screening phase) and day 29/30 if applicable)
Symptom index measurement in parallel to the pH measurement by intraluminal impedance(At day -1 (screening phase) and day 29/30 if applicable)
Global assessment of efficacy judged by patient using a five point Likert scale(At day 28)
Global assessment of efficacy judged by physician using a five point Likert scale(At day 28)
Change of Individual symptom score from baseline at the end of study (day 28)(At baseline and day 28)