Pepsin in Patients With Functional Dyspepsia

NCT03076411 | Completed

• 1 other identifier: NM-Efo-401
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Dyspepsia; Observational trial; Enzyme therapy; Pepsin

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Symptom Score (GIS)

  This is a third party assessment form.

  6 weeks

Secondary Outcomes (4)

• Tolerability assessed by Adverse Events

  6 weeks

• Subjective assessment of efficacy (4 point Likert scale)

  6 weeks

• Subjective assessment of feasibility of use (4 point Likert scale)

  6 weeks

• Symptomatology

  6 weeks

Interventions

Pepsin DRUG

Also known as: amino acid hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Unwilling to consent

Sponsors & Collaborators

• Nordmark Arzneimittel GmbH & Co. KG: lead
• ClinSupport GmbH: collaborator
• MWI Medizinisches Wirtschaftsinstitut GmbH: collaborator
• das forschungsdock: collaborator

Study Sites (1)

Immanuel Krankenhaus

Berlin, Germany

Location

Related Publications (1)

• Forssmann K, Meier L, Uehleke B, Breuer C, Stange R. A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia. BMC Gastroenterol. 2017 Nov 25;17(1):123. doi: 10.1186/s12876-017-0675-9.

  PMID: 29178842 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Abdominal Pain; Dyspepsia; Nausea; Vomiting; Flatulence

Interventions

Pepsin A

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Aspartic Acid Endopeptidases; Aspartic Acid Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases

Study Officials

• Kristin Forssmann, MD

  Nordmark Arzneimittel GmbH & Co. KG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: March 10, 2017
• Study Start: January 11, 2012
• Primary Completion: December 19, 2013
• Study Completion: June 16, 2015
• Last Updated: March 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)