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Pepsin in Patients With Functional Dyspepsia

NCT03076411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2017-03-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pepsin

Sponsors & Collaborators

  • ClinSupport GmbH

    collaborator INDUSTRY

  • MWI Medizinisches Wirtschaftsinstitut GmbH

    collaborator UNKNOWN

  • das forschungsdock

    collaborator UNKNOWN

  • Nordmark Arzneimittel GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Kristin Forssmann, MD · Nordmark Arzneimittel GmbH & Co. KG

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-11
Primary Completion
2013-12-19
Completion
2015-06-16

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03076411 on ClinicalTrials.gov