Clinical trial NCT04059900: Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Functional Gastrointestinal Disorders
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-08-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. Patients of either sex aged 18-80 years.
2. 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.
3. 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.
4. 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).
5. Patients willing to comply with the study protocol.
6. Patients who were able to understand and provide written informed consent to participate in the trial (signed informed consent).

Exclusion Criteria:

1. 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).
2. Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2 (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
3. History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer.
4. History of gastric and/or duodenal ulcer.
5. History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
6. History and/or presence of coronary heart disease.
7. Known intolerance to azo dyes E 110 and E 151.
8. Food allergies and known lactose intolerance.
9. Evidence of any gastrointestinal infectious diseases.
10. Participation in a clinical trial 30 days prior to this trial.
11. Concurrent participation in another clinical trial.
12. Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
13. History and/or presence of drug or alcohol abuse.
14. Patients with psychiatric illness.
15. Irritable bowel syndrome.

Primary outcomes:
measure: AUC of Patients' assessment of gastrointestinal symptoms evaluated by a daily measured VAS scale.
timeFrame: Up to 28 days
Secondary outcomes:
measure: Global Subject Outcome Assessment at visit 5
timeFrame: At day 28 (visit 5)
measure: Change of the Gastrointestinal Symptoms Profile (GIS) from baseline (visit 3) at the end of study (day 28)
timeFrame: At baseline and day 28
measure: AUC of reflux symptoms assessment measured by daily VAS scale
timeFrame: Up to 28 days
measure: Quality of Life evaluation as assessed by Functional Dyspepsia Quality of Life (FDDQL)
timeFrame: At baseline and day 28
measure: Relative time with an esophageal pH < 4 during 24 hours of measurement by Bravo™ pH system
timeFrame: At day -7/ -5 (screening phase) and day 29/30 if applicable
measure: Relative time with an esophageal pH < 4 during 24 hours of measurement using intraluminal impedance
timeFrame: At day -1 (screening phase) and day 29/30 if applicable
measure: Calculation of the DeMeester Score measured based on Bravo™ pH system
timeFrame: At day -7/ -5 (screening phase) and day 29/30 if applicable
measure: System index measurement in parallel to the pH measurement by Bravo™ pH system
timeFrame: At day -7/ -5 (screening phase) and day 29/30 if applicable
measure: Calculation of the DeMeester Score based on intraluminal impedance
timeFrame: At day -1 (screening phase) and day 29/30 if applicable
measure: 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
timeFrame: At day -1 (screening phase) and day 29/30 if applicable
measure: Symptom index measurement in parallel to the pH measurement by intraluminal impedance
timeFrame: At day -1 (screening phase) and day 29/30 if applicable
measure: Global assessment of efficacy judged by patient using a five point Likert scale
timeFrame: At day 28
measure: Global assessment of efficacy judged by physician using a five point Likert scale
timeFrame: At day 28
measure: Change of Individual symptom score from baseline at the end of study (day 28)
timeFrame: At baseline and day 28
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: