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Completed

NCT Number: NCT03076411

Pepsin in Patients With Functional Dyspepsia

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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Key information

Conditions

Functional Gastrointestinal Disorders Abdominal Pain Digestive System Diseases Dyspepsia Flatulence Gastrointestinal Diseases Nausea Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Immanuel Krankenhaus

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unwilling to consent

Treatment and study plan

Pepsin

Drug

Other names: amino acid hydrochloride

Primary outcomes

  1. Gastrointestinal Symptom Score (GIS)

    Time frame: 6 weeks

    This is a third party assessment form.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nordmark Arzneimittel GmbH & Co. KG

Industry

Collaborators

  • ClinSupport GmbH
  • MWI Medizinisches Wirtschaftsinstitut GmbH
  • das forschungsdock

Registry information

Official study title

A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Mar 10, 2017
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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