NCT04059900

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	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

Timeline

• Start date: 2009-06-18
• Primary completion: 2013-05-03
• Completion: 2013-05-03
• First posted: 2019-08-16
• Last updated: 2019-09-19

Locations

1 site across 1 country: Germany