Abdominal Pain, Dyspepsia, Flatulence, Functional Gastrointestinal Disorders, Nausea, Vomiting
Conditions
Keywords
Dyspepsia, Observational trial, Enzyme therapy, Pepsin
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.
Interventions
DRUGPepsin
Sponsors
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
das forschungsdock
Nordmark Arzneimittel GmbH & Co. KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with dyspepsia * Women and men aged between 18 and 75
Exclusion criteria
\- Unwilling to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Score (GIS) | 6 weeks | This is a third party assessment form. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Symptomatology | 6 weeks | Nepean Dyspepsia Index (NDI) modified |
Countries
Germany
Outcome results
None listed