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Esomeprazole and Gastric Emptying of Beer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472550
First Posted: May 11, 2007
Last Update Posted: May 11, 2007
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.
Information provided by:
Heidelberg University
  Purpose

To investigate the effect of 20 mg esomeprazole daily for one week on gastric emptying of 500 ml beer, the consecutive blood alcohol levels, the gastroesophageal reflux and plasma levels of gastrin and CCK in a randomized, placebo-controlled, double-blinded manner in 16 healthy male volunteers.

Hypothesis:

The combined taking of esomeprazole and beer will inhibit gastric emptying as compared to the intake of beer alone. This will induce a delay of the ethanol absorption and of the consecutive blood ethanol concentrations. Gastric acid secretion after beer will be reduced after esomeprazole treatment. Therefore, gastroesophageal acid reflux will be reduced after the combined taking. We speculate that gastrin, but not CCK plasma levels, will be increased after the combined taking as compared to beer alone. Both, beer and PPIs, have stimulatory effects on gastrin release. However, the secretion of CCK from duodenal CCK-cells is inhibited when gastric emptying is prolonged.


Condition Intervention Phase
Gastroesophageal Reflux Heartburn Drug: esomeprazole 20 mg Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Esomeprazole on Gastric Emptying of Alcoholic Beverages, Blood Alcohol Concentrations, Gastroesophageal Reflux and Release of Some Gastrointestinal Hormones in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Gastric emptying time, gastroesophageal reflux [ Time Frame: 3h ]

Secondary Outcome Measures:
  • blood ethanol concentration, CCK-levels, gastrin-levels, dyspeptic symptoms [ Time Frame: 3h ]

Enrollment: 16
Study Start Date: January 2006
Study Completion Date: November 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, non-smoking volunteers without regular medication or regular alcohol consumption will be included.
  • Before inclusion blood will be drawn and the following blood count, liver, pancreas, kidney, thyroid and coagulation parameters will be examined:

    • Creatinine (0.5 – 1.3 mg/dl),
    • Alc. Phosphatase (38 - 126 U/l),
    • GGT (0 - 85 U/l),
    • ALAT (0 - 50 U/l),
    • ASAT (0 - 37 U/l),
    • LDH (0 - 248 U/l),
    • Cholinesterase (>7000 U/l),
    • Amylase (25 - 130 U/l),
    • Lipase (114 - 300 U/l),
    • Leucocytes (3,5 – 11.0 10E9/L),
    • Erythrocytes (4.0 – 5.9 10E12/L),
    • Hb (12.0 – 17.5 g/dl),
    • Ht (33 – 50%),
    • Platelets (145 – 440 10E9/L),
    • CrP (< 10 mg/l),
    • TSH (0.4 - 5.0 mE/l),
    • fT4 (6 - 23 pmol/l),
    • INR (0.75 – 1.30),
    • PTT (15.0 – 33.0 sec.)

The results have to be within the physiological range (as given in parenthesis).

Moreover, volunteers have mentally to be able to understand the explanations concerning the study and follow to the instructions of the investigator.

Exclusion Criteria:

  • Any acute or chronic disease,
  • Heartburn more than once weekly,
  • Alcohol consumption of more than 50 g ethanol-equivalent per week,
  • Smoking,
  • Known hypersensitivity against esomeprazole,
  • Benzimidazole or other ingredients of the medication,
  • Fructose-intolerance,
  • Glucose-galactose-malabsorption or saccharase-isomaltase-deficiency.
  Contacts and Locations
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): NCT00472550


Locations
Germany
Dep. Medicine II, University Hospital Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Andreas Franke, MD Dep. Medicine II, University hospital Mannheim
  More Information

ClinicalTrials.gov Identifier: NCT00472550     History of Changes
Other Study ID Numbers: Mannheim-Eso-001
First Submitted: May 10, 2007
First Posted: May 11, 2007
Last Update Posted: May 11, 2007
Last Verified: May 2007

Keywords provided by Heidelberg University:
esomeprazole, gastric emptying, reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action