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 Type
OBSERVATIONAL
Enrollment
97
Immanuel Krankenhaus
Berlin, Germany
Gastrointestinal Symptom Score (GIS)
This is a third party assessment form.
Time frame: 6 weeks
Tolerability assessed by Adverse Events
Adverse Events
Time frame: 6 weeks
Subjective assessment of efficacy (4 point Likert scale)
Patient overall assessment (very good, good, moderate, no effect)
Time frame: 6 weeks
Subjective assessment of feasibility of use (4 point Likert scale)
Patient overall assessment (very good, good, moderate, no effect)
Time frame: 6 weeks
Symptomatology
Nepean Dyspepsia Index (NDI) modified
Time frame: 6 weeks
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