Pharmacokinetic properties of esomeprazole in adolescent patients aged 12 to 17 years with symptoms of gastroesophageal reflux disease: A randomized, open-label study

Clinical Therapeutics

Volumn 28, Issue 3, 2006, Pages 419-427

  Li, Jianguo ^a   Zhao, June ^a   Hamer Maansson, Jennifer E ^a   Andersson, Tommy ^a   Fulmer, Rose ^a   Illueca, Marta ^a   Lundborg, Per ^b  

^a ASTRAZENECA   (United Kingdom)

^b ASTRAZENECA R AND D   (Sweden)

Author keywords

adolescents; esomeprazole; gastroesophageal reflux disease; pediatric; pharmacokinetics

Indexed keywords

ESOMEPRAZOLE; ANTIULCER AGENT; OMEPRAZOLE;

ADOLESCENT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; FEMALE; GASTROESOPHAGEAL REFLUX; HUMAN; JOINT SWELLING; LABORATORY TEST; LIQUID CHROMATOGRAPHY; MALE; OPEN STUDY; PHYSICAL EXAMINATION; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; TOOTH PAIN; ULTRAVIOLET RADIATION; UNITED STATES; VITAL SIGN; VOMITING; BLOOD; CHILD; DOSE RESPONSE; TIME; TREATMENT OUTCOME;

ADOLESCENT; ANTI-ULCER AGENTS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GASTROESOPHAGEAL REFLUX; HUMANS; MALE; OMEPRAZOLE; TIME FACTORS; TREATMENT OUTCOME;

EID: 33745613852     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2006.03.010     Document Type: Article

References (20)

1. Rudolph C.D., Mazur L.J., Liptak G.S., et al., North American Society for Pediatric Gastroenterology and Nutrition. Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: Recommendations of the North American Society forPediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr. 32 Suppl 2 (2001) S1-S31
2. Nelson S.P., Chen E.H., Syniar G.M., Christoffel K.K., and Pediatric Practice Research Group. Prevalence of symptoms of gastroesophageal reflux during childhood: A pediatric practice-based survey. Arch Pediatr Adolesc Med 154 (2000) 150-154
3. Locke III G.R., Talley N.J., Fett S.L., et al. Prevalence and clinical spectrum of gastroesophageal reflux: A populationbased study in Olmsted County, Minnesota. Gastroenterology 112 (1997) 1448-1456
4. Gunasekaran T., Gupta S., Gremse D., et al. Lansoprazole in adolescents with gastroesophageal reflux disease: Pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability. J Pediatr Gastroenterol Nutr 35 Suppl 4 (2002) S327-S335
5. Tolia V., Ferry G., Gunasekaran T., et al. Efficacy of lansoprazole in the treatment ofgastroesophageal reflux disease in children. J Pediatr Gastroenterol Nutr 35 Suppl 4 (2002) 5308-5318
6. Hassall E., Israel D., Shepherd R., et al., International Pediatric Omeprazole Study Group. Omeprazole for treatment of chronic erosive esophagitis in children: A multicenter study ofefficacy, safety, tolerability and dose requirements. J Pediatr 137 (2000) 800-807
7. Franco M.T., Salvia G., Terrin G., et al. Lansoprazole in the treatment of gastro-oesophageal reflux disease in childhood. Dig Liver Dis 32 (2000) 660-666
8. Miner Jr. P., Katz P.O., Chen Y., and Sostek M. Gastric acid control with esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole: A five-way crossover study. Am J Gastroenterol 98 (2003) 2616-2620
9. Letter. Miner Jr. P., Katz P.O., Chen Y., and Sostek M. Reanalysis of intragastric pH results based on updated correction factors for Slimline® and Zinetics™ 24 single-use pH catheters. Am J Gastroenterol 101 (2006) 404-405
10. Andersson T., Hassan-Alin M., Hasselgren G., et al. Pharmacokinetic studies with esomeprazole, the (S) isomer of omeprazole. Clin Pharmacokinet 40 (2001) 411-426
11. [WMA Web site]. World Medical Association Declaration of Helsinki. Recommendations Guiding Medical Doctors in Bio medical Research Involving Human Subjects. Available at: (1989), WMA, FerneyVoltaire, France. http://www.wma.net
12. [EMEA Web site]. ICH Topic E6. European Agency for the Evaluation of Medicinal Products, International Conference on HarmonisationWorld Health Organization. Guideline for Good Clinical Practice. Available at: (2002), WHO, Geneva, Switzerland. http://www.emea.eu.int
13. Lagerstrom P.O., and Persson B.A. Determination of omeprazole and metabolites in plasma and urine by liquid chromatography. J Chromatogr 309 (1984) 347-356
14. Hassan-Alin M., Andersson T., Bredberg E., and Rohss K. Pharmacokinetics of esomeprazole after oral and intravenous administration of single and repeated doses to healthy subjects. Eur J Clin Pharmacol 56 (2000) 665-670
15. Andersson T., Rohss K., Bredberg E., and Hassan-Alin M. Pharmacokinetics and pharmacodynamics of esomep razole, the S-isomer of omeprazole. Aliment Pharmacol Ther 15 (2001) 1563-1569
16. Lind T., Rydberg L., Kyleback A., et al. Esomeprazole provides improved acid control vs. omeprazole in pa tients with symptoms of gastrooesophageal reflux disease. Aliment Pharmacol Ther 14 (2000) 861-867
17. [prescribing information]. Nexium (esomeprazole magnesium) delayed-release capsules. Accessed (2005), AstraZeneca LP, Wilmington, Del. http://www.astrazeneca Accessed
18. Kearns G.L., Andersson T., James L.P., et al. Omeprazole disposition in children following single-dose adminis tration. J Clin Pharmacol 43 (2003) 840-848
19. Tran A., Rey E., Pons G., et al. Pharmacokinetic-pharmacodynamic study of oral lansoprazole in children. Clin Pharmacol Ther 71 (2002) 359-367
20. Andersson T., Hassall E., Lundborg P., et al., International Pediatric Omeprazole Pharmacokinetic Group. Pharmacokinetics of orally administered omeprazole in children. Am J Gastroenterol 95 (2000) 3101-3106