Pepsin in Patients With Functional Dyspepsia

Nordmark Pharma

Status: Completed

Conditions: Flatulence; Vomiting; Nausea; Functional Gastrointestinal Disorders; Dyspepsia; Abdominal Pain

Treatments: Drug: Pepsin

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03076411

NM-Efo-401

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with dyspepsia
• Women and men aged between 18 and 75

Exclusion criteria

• Unwilling to consent