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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03076411
Study type Observational
Source Nordmark Arzneimittel GmbH & Co. KG
Contact
Status Completed
Phase N/A
Start date January 11, 2012
Completion date June 16, 2015

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