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NCT03076411 Clinical Trial

Pepsin in Patients With Functional Dyspepsia

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03076411
Other study ID # NM-Efo-401
Secondary ID
Status Completed
Phase N/A
First received October 19, 2016
Last updated March 6, 2017
Start date January 11, 2012
Est. completion date June 16, 2015

Study information
Verified date March 2017
Source Nordmark Arzneimittel GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date June 16, 2015
Est. primary completion date December 19, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with dyspepsia

- Women and men aged between 18 and 75

Exclusion Criteria:

- Unwilling to consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pepsin

Locations
Country Name City State
Germany Immanuel Krankenhaus Berlin

Sponsors (4)
Lead Sponsor Collaborator
Nordmark Arzneimittel GmbH & Co. KG ClinSupport GmbH, das forschungsdock, MWI Medizinisches Wirtschaftsinstitut GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastrointestinal Symptom Score (GIS) This is a third party assessment form. 6 weeks
Secondary Tolerability assessed by Adverse Events Adverse Events 6 weeks
Secondary Subjective assessment of efficacy (4 point Likert scale) Patient overall assessment (very good, good, moderate, no effect) 6 weeks
Secondary Subjective assessment of feasibility of use (4 point Likert scale) Patient overall assessment (very good, good, moderate, no effect) 6 weeks
Secondary Symptomatology Nepean Dyspepsia Index (NDI) modified 6 weeks
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