Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472550
Status:
COMPLETED
Last Update Posted:
2007-05-11
First Post:
2007-05-10
Brief Title:
Esomeprazole and Gastric Emptying of Beer
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 determined The sequence of the tests verum or placebo will be randomised in a cross over design In each subject at most one test will be performed every 2 weeks to ensure one week without treatment wash-out-phase between both experiments
All examinations will be performed in the afternoon After a small breakfast in the morning subjects fast for at least 8 hours During the examination all subjects are sitting slightly leaned backwards A double lumen nasogastric tube Ch 14 Laboratories Pharmaceutiques Vygon Ecouen France will be positioned in the most dependent part of the stomach and a pH-probe F8IR blue line SME Medizintechnik Weil am Rhein will be positioned 5 cm above the lower esophageal sphincter 500 ml beer will then be instilled into the stomach over 5 min Gastric emptying will be determined every 10 min for 2 hours by ultrasonography
Withdrawal criteria The trial can be stopped anytime by the volunteer without specified reasons or by the investigator in case of incompliance of the volunteer or subsequent incidence of exclusion criteria In case of hypersensitive or allergic reaction against the medication or side effects of the medication such as urtication angioneurotic edema vomiting cardiovascular reaction systolic blood pressure under 100 mmHg paraesthesia confusion bronchial spasm or fever the study will also be stopped
In case of withdrawal of volunteers up to four additional volunteers can be recruited to complete totalling 16 volunteers
Assessment of safety Esomeprazole is a frequently administered drug in the therapy of particularly gastroesophageal reflux disease gastritis and gastric or duodenal ulcers Side effects are very rare headache abdominal pain diarrhoea bloating nausea vomiting and constipation are thereof the most frequent The methods used in this study are clinical routine procedures and imply -if used by skilful physicians as in this study - no risk for complications
To detect side effects or complications the investigator is present in the examination room during the whole study and blood pressure and heart rate are measured every 15 minutes Before the each study and during the introduction procedure a physical examination will be performed by the investigator
Ultrasonography Ultrasonography of the antrum and the fundus represents a highly reliable and reproducible radiation-avoiding method for determination of gastric emptying 11-14 To determine gastric emptying of the proximal and distal stomach we will use a curved array scanner with a 325 MHz ultrasound transducer Sonoline Sienna Siemens Germany We determine emptying of the distal stomach by measuring the cross-sectional area of the antrum at the level of the superior mesenteric vein and the aorta 12 13 The vessels are used to standardize the position of the scans This antral area is scanned before immediately after intragastrical application of the test solution and every 10 minutes for two hours
Gastic emptying of the proximal stomach will be measured immediately after the application and every 10 min until the fundus is emptied completely using the following ultrasonographic method the transducer will be positioned in the epigastrium at the left subcostal margin and tilted cranially The maximal angle of view of the scanner is used to visualize as much of the proximal stomach as possible Two standardized sonographic image sections are chosen First a sagital section with the left renal pelvis in a longitudinal projection the left lobe of the liver and the tail of the pancreas as internal landmarks The transducer is then rotated 90 clockwise to obtain an oblique frontal section where the left hemidiaphragm the top margin of the fundus and the liver parenchyma serve as landmarks A proximal gastric area is outlined in the sagital section by tracing from the top margin of the fundus and 7 cm downward along the axis of the stomach The maximal diameter in the oblique frontal section kept within 7 cm along the axis of the proximal stomach is chosen as the second measure Both measurements are combined to estimate an approximate volume of the fundus 11
The inner echogenic layer corresponding to the interface between the gastric content and the mucosa of the gastric wall is outlined The measurements were repeated twice and the mean value is used The areas of the antrum and the fundus and the diameter of the fundus are traced by the internal calliper provided with the ultrasound instrument All ultrasonographic parameters will be measured twice the mean of both measurements will be chosen to be representative
Gastric half emptying time t12 will determined separately for the fundus and the antrum
Plasma gastrin plasma CCK and serum ethanol concentrations Blood samples 10 ml will be drawn at baseline and every 15 min after application of the test solution for 2 hours for the determination of serum ethanol concentrations Samples will be centrifuged immediately at 4 C The serum concentration of ethanol will be determined using the alcohol-dehydrogenase method Ethylalkohol Roche Diagnostics GmbH Mannheim Germany The plasma concentrations of gastrin will be measured by the Institute for Clinical Chemistry at the University Hospital Mannheim by radioimmunassays RIA and that of CCK at the Universityhospital Basel Professor Ch Beglinger no round robin test certificate available
Gastroesophageal reflux The intraesophageal pH 5 cm above the lower esophageal sphincter will be recorded for 4 hours by GastroScan II SME Medizintechnik Sprendlingen The correct position of the tip of the pH-probe will be measured by pH-metry during the visit for the screening examinations The portion of intraesophageal pH4 and the DeMeester-Score frequency and duration of pH4 will be calculated
Gastrointestinal complaints The volunteers mark additionally on a visual analogue scale VAS 0-100 their intensity of fullness bloating heartburn and satiety before the ingestion of beer and than in 10 min intervals for 2 hours
Statistical analysis Statistical significances for differences between gastric emptying rates blood alcohol concentrations and gastroesophageal reflux will be determined using students t-test
All examinations will be performed in the afternoon After a small breakfast in the morning subjects fast for at least 8 hours During the examination all subjects are sitting slightly leaned backwards A double lumen nasogastric tube Ch 14 Laboratories Pharmaceutiques Vygon Ecouen France will be positioned in the most dependent part of the stomach and a pH-probe F8IR blue line SME Medizintechnik Weil am Rhein will be positioned 5 cm above the lower esophageal sphincter 500 ml beer will then be instilled into the stomach over 5 min Gastric emptying will be determined every 10 min for 2 hours by ultrasonography
Withdrawal criteria The trial can be stopped anytime by the volunteer without specified reasons or by the investigator in case of incompliance of the volunteer or subsequent incidence of exclusion criteria In case of hypersensitive or allergic reaction against the medication or side effects of the medication such as urtication angioneurotic edema vomiting cardiovascular reaction systolic blood pressure under 100 mmHg paraesthesia confusion bronchial spasm or fever the study will also be stopped
In case of withdrawal of volunteers up to four additional volunteers can be recruited to complete totalling 16 volunteers
Assessment of safety Esomeprazole is a frequently administered drug in the therapy of particularly gastroesophageal reflux disease gastritis and gastric or duodenal ulcers Side effects are very rare headache abdominal pain diarrhoea bloating nausea vomiting and constipation are thereof the most frequent The methods used in this study are clinical routine procedures and imply -if used by skilful physicians as in this study - no risk for complications
To detect side effects or complications the investigator is present in the examination room during the whole study and blood pressure and heart rate are measured every 15 minutes Before the each study and during the introduction procedure a physical examination will be performed by the investigator
Ultrasonography Ultrasonography of the antrum and the fundus represents a highly reliable and reproducible radiation-avoiding method for determination of gastric emptying 11-14 To determine gastric emptying of the proximal and distal stomach we will use a curved array scanner with a 325 MHz ultrasound transducer Sonoline Sienna Siemens Germany We determine emptying of the distal stomach by measuring the cross-sectional area of the antrum at the level of the superior mesenteric vein and the aorta 12 13 The vessels are used to standardize the position of the scans This antral area is scanned before immediately after intragastrical application of the test solution and every 10 minutes for two hours
Gastic emptying of the proximal stomach will be measured immediately after the application and every 10 min until the fundus is emptied completely using the following ultrasonographic method the transducer will be positioned in the epigastrium at the left subcostal margin and tilted cranially The maximal angle of view of the scanner is used to visualize as much of the proximal stomach as possible Two standardized sonographic image sections are chosen First a sagital section with the left renal pelvis in a longitudinal projection the left lobe of the liver and the tail of the pancreas as internal landmarks The transducer is then rotated 90 clockwise to obtain an oblique frontal section where the left hemidiaphragm the top margin of the fundus and the liver parenchyma serve as landmarks A proximal gastric area is outlined in the sagital section by tracing from the top margin of the fundus and 7 cm downward along the axis of the stomach The maximal diameter in the oblique frontal section kept within 7 cm along the axis of the proximal stomach is chosen as the second measure Both measurements are combined to estimate an approximate volume of the fundus 11
The inner echogenic layer corresponding to the interface between the gastric content and the mucosa of the gastric wall is outlined The measurements were repeated twice and the mean value is used The areas of the antrum and the fundus and the diameter of the fundus are traced by the internal calliper provided with the ultrasound instrument All ultrasonographic parameters will be measured twice the mean of both measurements will be chosen to be representative
Gastric half emptying time t12 will determined separately for the fundus and the antrum
Plasma gastrin plasma CCK and serum ethanol concentrations Blood samples 10 ml will be drawn at baseline and every 15 min after application of the test solution for 2 hours for the determination of serum ethanol concentrations Samples will be centrifuged immediately at 4 C The serum concentration of ethanol will be determined using the alcohol-dehydrogenase method Ethylalkohol Roche Diagnostics GmbH Mannheim Germany The plasma concentrations of gastrin will be measured by the Institute for Clinical Chemistry at the University Hospital Mannheim by radioimmunassays RIA and that of CCK at the Universityhospital Basel Professor Ch Beglinger no round robin test certificate available
Gastroesophageal reflux The intraesophageal pH 5 cm above the lower esophageal sphincter will be recorded for 4 hours by GastroScan II SME Medizintechnik Sprendlingen The correct position of the tip of the pH-probe will be measured by pH-metry during the visit for the screening examinations The portion of intraesophageal pH4 and the DeMeester-Score frequency and duration of pH4 will be calculated
Gastrointestinal complaints The volunteers mark additionally on a visual analogue scale VAS 0-100 their intensity of fullness bloating heartburn and satiety before the ingestion of beer and than in 10 min intervals for 2 hours
Statistical analysis Statistical significances for differences between gastric emptying rates blood alcohol concentrations and gastroesophageal reflux will be determined using students t-test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None