Esomeprazole and Gastric Emptying of Beer - Full Text View

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00472550

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 IV

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:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

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

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

University of Heidelberg

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 University of Heidelberg:

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
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012