Pepsin in Patients With Functional Dyspepsia

March 6, 2017 updated by: Nordmark Arzneimittel GmbH & Co. KG

A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Immanuel Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presented with acute and chronic gastrointestinal symptoms, it was decided on the basis of their history, previous findings (diagnostic endoscopy and imaging, if available) and findings on physical examination whether they could participate in the postmarketing surveillance.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Unwilling to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Symptom Score (GIS)
Time Frame: 6 weeks
This is a third party assessment form.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability assessed by Adverse Events
Time Frame: 6 weeks
Adverse Events
6 weeks
Subjective assessment of efficacy (4 point Likert scale)
Time Frame: 6 weeks
Patient overall assessment (very good, good, moderate, no effect)
6 weeks
Subjective assessment of feasibility of use (4 point Likert scale)
Time Frame: 6 weeks
Patient overall assessment (very good, good, moderate, no effect)
6 weeks
Symptomatology
Time Frame: 6 weeks
Nepean Dyspepsia Index (NDI) modified
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordmark Arzneimittel GmbH & Co. KG

Collaborators

ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
das forschungsdock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 11, 2012

Primary Completion (ACTUAL)

December 19, 2013

Study Completion (ACTUAL)

June 16, 2015

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

March 6, 2017

First Posted (ACTUAL)

March 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-Efo-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dyspepsia

Clinical Trials on Pepsin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe