Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus

NCT04059900 | Completed Phase 2

• 2 other identifiers: 209852008-002305-40
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 28 days

Secondary Outcomes (14)

• Global Subject Outcome Assessment at visit 5

  At day 28 (visit 5)

• 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

Study Arms (2)

STW5 (Iberogast®, BAY98-7411)

EXPERIMENTAL

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.

Drug: STW5 (Iberogast®, BAY98-7411)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

STW5 (Iberogast®, BAY98-7411) DRUG

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.

STW5 (Iberogast®, BAY98-7411)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who were able to understand and provide written informed consent to participate in the trial (signed informed consent).

You may not qualify if:

• 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 151.
• Food allergies and known lactose intolerance.
• Evidence of any gastrointestinal infectious diseases.
• Participation in a clinical trial 30 days prior to this trial.
• Concurrent participation in another clinical trial.
• Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
• History and/or presence of drug or alcohol abuse.
• Patients with psychiatric illness.
• Irritable bowel syndrome.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Germany

Location

Related Links

• Click here to find results for studies related to Bayer products
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

iberogast

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: August 16, 2019
• Study Start: June 18, 2009
• Primary Completion: May 3, 2013
• Study Completion: May 3, 2013
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

DE (1)