Pepsin in Patients With Functional Dyspepsia

• Sponsor: Nordmark Arzneimittel GmbH & Co. KG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03076411
• Collaborator: ClinSupport GmbH (Industry), MWI Medizinisches Wirtschaftsinstitut GmbH (Other), das forschungsdock (Other)
• Enrollment: 97
• Location: 1
• Actual Duration (Months): 41.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Gastrointestinal Disorders; Abdominal Pain; Dyspepsia; Nausea; Vomiting; Flatulence	Drug: Pepsin

Study Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia
• Actual Study Start Date: Jan 11, 2012
• Actual Primary Completion Date: Dec 19, 2013
• Actual Study Completion Date: Jun 16, 2015

Outcome Measures

Primary Outcome Measures

1. Gastrointestinal Symptom Score (GIS) [6 weeks]

   This is a third party assessment form.

Secondary Outcome Measures

1. Tolerability assessed by Adverse Events [6 weeks]

   Adverse Events

2. Subjective assessment of efficacy (4 point Likert scale) [6 weeks]

   Patient overall assessment (very good, good, moderate, no effect)

3. Subjective assessment of feasibility of use (4 point Likert scale) [6 weeks]

   Patient overall assessment (very good, good, moderate, no effect)

4. Symptomatology [6 weeks]

   Nepean Dyspepsia Index (NDI) modified

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with dyspepsia

• Women and men aged between 18 and 75

Exclusion Criteria:

• Unwilling to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Immanuel Krankenhaus	Berlin		Germany

Sponsors and Collaborators

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

Investigators

• Study Director: Kristin Forssmann, MD, Nordmark Arzneimittel GmbH & Co. KG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nordmark Arzneimittel GmbH & Co. KG
• ClinicalTrials.gov Identifier: NCT03076411
• Other Study ID Numbers: NM-Efo-401
• First Posted: Mar 10, 2017
• Last Update Posted: Mar 10, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nordmark Arzneimittel GmbH & Co. KG: Dyspepsia; Observational trial; Enzyme therapy; Pepsin
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Vomiting; Dyspepsia; Abdominal Pain; Flatulence

Study Results

No Results Posted as of Mar 10, 2017