Status:
COMPLETED
Esomeprazole and Gastric Emptying of Beer
Lead Sponsor:
Heidelberg University
Conditions:
Gastroesophageal Reflux
Heartburn
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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 an...
Detailed Description
Sixteen healthy, male and non-smoking volunteers will be enrolled in this study. The subjects will be treated with placebo or with 20 mg esomeprazole daily for one week before gastric emptying will be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00472550
Start Date
January 1 2006
End Date
November 1 2006
Last Update
May 11 2007
Active Locations (1)
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1
Dep. Medicine II, University Hospital Mannheim
Mannheim, Germany, 68167