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Pepsin in Patients With Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076411
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Collaborators:
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
das forschungsdock
Information provided by (Responsible Party):
Nordmark Arzneimittel GmbH & Co. KG

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
Functional Gastrointestinal Disorders Abdominal Pain Dyspepsia Nausea Vomiting Flatulence Drug: Pepsin

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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 : January 11, 2012
Actual Primary Completion Date : December 19, 2013
Actual Study Completion Date : June 16, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion


Intervention Details:
  • Drug: Pepsin
    Other Name: amino acid hydrochloride


Primary Outcome Measures :
  1. Gastrointestinal Symptom Score (GIS) [ Time Frame: 6 weeks ]
    This is a third party assessment form.


Secondary Outcome Measures :
  1. Tolerability assessed by Adverse Events [ Time Frame: 6 weeks ]
    Adverse Events

  2. Subjective assessment of efficacy (4 point Likert scale) [ Time Frame: 6 weeks ]
    Patient overall assessment (very good, good, moderate, no effect)

  3. Subjective assessment of feasibility of use (4 point Likert scale) [ Time Frame: 6 weeks ]
    Patient overall assessment (very good, good, moderate, no effect)

  4. Symptomatology [ Time Frame: 6 weeks ]
    Nepean Dyspepsia Index (NDI) modified



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Unwilling to consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076411


Locations
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Germany
Immanuel Krankenhaus
Berlin, Germany
Sponsors and Collaborators
Nordmark Arzneimittel GmbH & Co. KG
ClinSupport GmbH
MWI Medizinisches Wirtschaftsinstitut GmbH
das forschungsdock
Investigators
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Study Director: Kristin Forssmann, MD Nordmark Arzneimittel GmbH & Co. KG

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nordmark Arzneimittel GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03076411     History of Changes
Other Study ID Numbers: NM-Efo-401
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Gastrointestinal Diseases
Vomiting
Dyspepsia
Abdominal Pain
Flatulence
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Pepsin A
Gastrointestinal Agents