NCT03076411

Pepsin in Patients With Functional Dyspepsia

A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 97 (actual)
• Sponsor: Nordmark Arzneimittel GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.

Conditions

• Functional Gastrointestinal Disorders
• Abdominal Pain
• Dyspepsia
• Nausea
• Vomiting
• Flatulence

Interventions

Type	Name	Description
DRUG	Pepsin

Timeline

• Start date: 2012-01-11
• Primary completion: 2013-12-19
• Completion: 2015-06-16
• First posted: 2017-03-10
• Last updated: 2017-03-10

Locations

1 site across 1 country: Germany