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Pepsin in Patients With Functional Dyspepsia

NCT ID: NCT03076411

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-11

Study Completion Date

2015-06-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Functional Gastrointestinal Disorders Abdominal Pain Dyspepsia Nausea Vomiting Flatulence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pepsin

Intervention Type DRUG

Other Intervention Names

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amino acid hydrochloride

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- Unwilling to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ClinSupport GmbH

INDUSTRY

Sponsor Role collaborator

MWI Medizinisches Wirtschaftsinstitut GmbH

UNKNOWN

Sponsor Role collaborator

das forschungsdock

UNKNOWN

Sponsor Role collaborator

Nordmark Arzneimittel GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin Forssmann, MD

Role: STUDY_DIRECTOR

Nordmark Arzneimittel GmbH & Co. KG

Locations

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Immanuel Krankenhaus

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29178842 (View on PubMed)

Other Identifiers

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NM-Efo-401

Identifier Type: -

Identifier Source: org_study_id

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