Trial | NCT03076411  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Observational

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pepsin ...

  • Study Participants

    97
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.
Study Started
Jan 11
2012
Primary Completion
Dec 19
2013
Study Completion
Jun 16
2015
Last Update
Mar 10
2017

Drug Pepsin

  • Other names: amino acid hydrochloride

Population

Patients presented with acute and chronic gastrointestinal symptoms, it was decided on the basis of their history, previous findings (diagnostic endoscopy and imaging, if available) and findings on physical examination whether they could participate in the postmarketing surveillance.

Criteria 

Inclusion Criteria:

Patients with dyspepsia
Women and men aged between 18 and 75

Exclusion Criteria:

- Unwilling to consent
No Results Posted