Pepsin in Patients With Functional Dyspepsia | NCT03076411

Studies
Pepsin in Patients With Functional Dyspepsia

NCT03076411

Sponsor

Nordmark Arzneimittel GmbH & Co. KG

Status

Completed

Last Update Posted

Mar 10, 2017Actual

Enrollment

97Actual

Phase

Not provided

Conditions

Functional Gastrointestinal Disorders
Abdominal Pain
Dyspepsia
Nausea
Vomiting
Flatulence

Interventions

Pepsin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2012Actual

Primary Completion Date

Dec 19, 2013Actual

Completion Date

Jun 16, 2015Actual

First Submitted Date

Oct 19, 2016

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 10, 2017Actual

Name	Class
ClinSupport GmbH	INDUSTRY
MWI Medizinisches Wirtschaftsinstitut GmbH	UNKNOWN
das forschungsdock	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Name	Type	Description	Arm Group Labels	Other Names
Pepsin	Drug			amino acid hydrochloride

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Tolerability assessed by Adverse Events	Adverse Events	6 weeks
Subjective assessment of efficacy (4 point Likert scale)	Patient overall assessment (very good, good, moderate, no effect)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with dyspepsia
Women and men aged between 18 and 75

Exclusion Criteria:

- Unwilling to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristin Forssmann, MD	Nordmark Arzneimittel GmbH & Co. KG	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Immanuel Krankenhaus		Berlin			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29178842	Derived	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.

ID	Term
D005767	Gastrointestinal Diseases
D015746	Abdominal Pain
D004415	Dyspepsia
D009325	Nausea
D014839	Vomiting
D005414	Flatulence

ID	Term
D004066	Digestive System Diseases
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D016282	Aspartic Acid Endopeptidases
D057055	Aspartic Acid Proteases
D010447	Peptide Hydrolases
D006867	Hydrolases