Esomeprazole and Gastric Emptying of Beer

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00472550
First received: May 10, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00472550     History of Changes
Other Study ID Numbers: Mannheim-Eso-001
Study First Received: May 10, 2007
Last Updated: May 10, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014