Pepsin in Patients With Functional Dyspepsia
- Conditions
- DyspepsiaAbdominal PainVomitingFlatulenceFunctional Gastrointestinal DisordersNausea
- Registration Number
- NCT03076411
- Lead Sponsor
- Nordmark Arzneimittel GmbH & Co. KG
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
- Patients with dyspepsia
- Women and men aged between 18 and 75
- Unwilling to consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastrointestinal Symptom Score (GIS) 6 weeks This is a third party assessment form.
- Secondary Outcome Measures
Name Time Method Symptomatology 6 weeks Nepean Dyspepsia Index (NDI) modified
Tolerability assessed by Adverse Events 6 weeks Adverse Events
Subjective assessment of efficacy (4 point Likert scale) 6 weeks Patient overall assessment (very good, good, moderate, no effect)
Subjective assessment of feasibility of use (4 point Likert scale) 6 weeks Patient overall assessment (very good, good, moderate, no effect)
Trial Locations
- Locations (1)
Immanuel Krankenhaus
🇩🇪Berlin, Germany