NCT03076411
Completed
Not Applicable
A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia
DrugsPepsin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- Nordmark Arzneimittel GmbH & Co. KG
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- Gastrointestinal Symptom Score (GIS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with dyspepsia
- •Women and men aged between 18 and 75
Exclusion Criteria
- •Unwilling to consent
Outcomes
Primary Outcomes
Gastrointestinal Symptom Score (GIS)
Time Frame: 6 weeks
This is a third party assessment form.
Secondary Outcomes
- Symptomatology(6 weeks)
- Tolerability assessed by Adverse Events(6 weeks)
- Subjective assessment of efficacy (4 point Likert scale)(6 weeks)
- Subjective assessment of feasibility of use (4 point Likert scale)(6 weeks)
Study Sites (1)
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