Esomeprazole and Gastric Emptying of Beer

NCT00472550 | Completed Phase 4 DMC

• 1 other identifier: Mannheim-Eso-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux; Heartburn

Keywords

esomeprazole, gastric emptying, reflux

Outcome Measures

Primary Outcomes (1)

• Gastric emptying time, gastroesophageal reflux

  3h

Secondary Outcomes (1)

• blood ethanol concentration, CCK-levels, gastrin-levels, dyspeptic symptoms

  3h

Interventions

esomeprazole 20 mg DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, non-smoking volunteers without regular medication or regular alcohol consumption will be included.
• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Dep. Medicine II, University Hospital Mannheim

Mannheim, 68167, Germany

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andreas Franke, MD

  Dep. Medicine II, University hospital Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: January 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 11, 2007

Record last verified: 2007-05

Locations

DE (1)