Clinical Trial: Pepsin in Patients With Functional Dyspepsia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: Nordmark Arzneimittel GmbH & Co. KG

Current Primary Outcome: Gastrointestinal Symptom Score (GIS) [ Time Frame: 6 weeks ]

This is a third party assessment form.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tolerability assessed by Adverse Events [ Time Frame: 6 weeks ]
    Adverse Events
  • Subjective assessment of efficacy (4 point Likert scale) [ Time Frame: 6 weeks ]
    Patient overall assessment (very good, good, moderate, no effect)
  • Subjective assessment of feasibility of use (4 point Likert scale) [ Time Frame: 6 weeks ]
    Patient overall assessment (very good, good, moderate, no effect)
  • Symptomatology [ Time Frame: 6 weeks ]
    Nepean Dyspepsia Index (NDI) modified


Original Secondary Outcome: Same as current

Information By: Nordmark Arzneimittel GmbH & Co. KG

Dates:
Date Received: October 19, 2016
Date Started: January 11, 2012
Date Completion:
Last Updated: March 6, 2017
Last Verified: March 2017