메뉴 건너뛰기




Volumn 50, Issue 8, 2011, Pages 541-550

Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease

Author keywords

Children; Gastro oesophageal reflux; Infants; Pantoprazole; Proton pump inhibitors

Indexed keywords

PANTOPRAZOLE;

EID: 79960201144     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.2165/11591900-000000000-00000     Document Type: Article
Times cited : (14)

References (36)
  • 1
    • 66949174822 scopus 로고    scopus 로고
    • A global, evidence-based consensus on the definition of gastroesophageal reflux disease in the pediatric population
    • Sherman PM, Hassall E, Fagundes-Neto U, et al. A global, evidence-based consensus on the definition of gastroesophageal reflux disease in the pediatric population. Am J Gastroenterol 2009; 104: 1278-95.
    • (2009) Am J Gastroenterol , vol.104 , pp. 1278-1295
    • Sherman, P.M.1    Hassall, E.2    Fagundes-Neto, U.3
  • 2
    • 70349742792 scopus 로고    scopus 로고
    • Pediatric gastroesophageal reflux clinical practice guidelines: Joint recommendations of the North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition
    • Sep 9
    • Vandenplas Y, Rudolph CD, Di Lorenzo C, et al. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr 2009 Sep 9; 49: 498-547.
    • (2009) J Pediatr Gastroenterol Nutr , vol.49 , pp. 498-547
    • Vandenplas, Y.1    Rudolph, C.D.2    Di Lorenzo, C.3
  • 3
    • 1442356576 scopus 로고    scopus 로고
    • Gastroesophageal reflux: A critical review of its role in preterm infants
    • Poets C. Gastroesophageal reflux: a critical review of its role in preterm infants. Pediatrics 2004; 113 (2): e128-32.
    • (2004) Pediatrics , vol.113 , Issue.2
    • Poets, C.1
  • 4
    • 1542545608 scopus 로고    scopus 로고
    • Are proton pump inhibitors indicated for the treatment of gastroesophageal reflux in infants and children?
    • Rudolph CD. Are proton pump inhibitors indicated for the treatment of gastroesophageal reflux in infants and children? J Pediatr Gastroenterol Nutr 2003; 37: S60-4.
    • (2003) J Pediatr Gastroenterol Nutr , vol.37
    • Rudolph, C.D.1
  • 5
    • 1542313848 scopus 로고    scopus 로고
    • Managing gastro-oesophageal reflux disease in children
    • Cezard J. Managing gastro-oesophageal reflux disease in children. Digestion 2004; 69 (Suppl. 1): S3-8.
    • (2004) Digestion , vol.69 , Issue.SUPPL. 1
    • Cezard, J.1
  • 6
    • 62649162766 scopus 로고    scopus 로고
    • Multicenter, double- blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease
    • Orenstein SR, Hassall E, Furmaga-Jablonska W, et al. Multicenter, double- blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr 2009; 154 (4): 514-20.
    • (2009) J Pediatr , vol.154 , Issue.4 , pp. 514-520
    • Orenstein, S.R.1    Hassall, E.2    Furmaga-Jablonska, W.3
  • 7
    • 77953166804 scopus 로고    scopus 로고
    • Efficacy and safety of pantoprazole delayed-release granules for oral suspension in a placebo-controlled treatment-withdrawal study in infants 1 through 11 months with symptomatic gastroesophageal reflux disease
    • June
    • Winter H, Kum-Nji P, Mahomedy S, et al. Efficacy and safety of pantoprazole delayed-release granules for oral suspension in a placebo-controlled treatment-withdrawal study in infants 1 through 11 months with symptomatic gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2010 June; 50 (6): 609-18.
    • (2010) J Pediatr Gastroenterol Nutr , vol.50 , Issue.6 , pp. 609-618
    • Winter, H.1    Kum-Nji, P.2    Mahomedy, S.3
  • 8
    • 78449258187 scopus 로고    scopus 로고
    • Esomeprazole for the treatment of gastroesophageal reflux disease (GERD) in infants [abstract no. T1123]
    • Winter H, Gunasekaran T, Tolia V, et al. Esomeprazole for the treatment of gastroesophageal reflux disease (GERD) in infants [abstract no. T1123]. Gastroenterology 2009; 136 (5 Suppl. 1): A-504.
    • (2009) Gastroenterology , vol.136 , Issue.5 SUPPL. 1
    • Winter, H.1    Gunasekaran, T.2    Tolia, V.3
  • 9
    • 77955485968 scopus 로고    scopus 로고
    • Clinical results from a randomized double- blind dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis
    • Sep
    • Baker R, Tsou VM, Tung J, et al. Clinical results from a randomized, double- blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila) 2010 Sep; 49 (9): 852-65.
    • (2010) Clin Pediatr (Phila) , vol.49 , Issue.9 , pp. 852-865
    • Baker, R.1    Tsou, V.M.2    Tung, J.3
  • 11
    • 33748502271 scopus 로고    scopus 로고
    • Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD)
    • DOI 10.1177/0009922806292792
    • Tsou VM, Baker R, Book L, et al. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clin Pediatr (Phila) 2006; 45 (8): 741-9. (Pubitemid 44359194)
    • (2006) Clinical Pediatrics , vol.45 , Issue.8 , pp. 741-749
    • Tsou, V.M.1    Baker, R.2    Book, L.3    Hammo, A.-H.4    Soffer, E.F.5    Wang, W.6    Comer, G.M.7
  • 12
    • 48249111016 scopus 로고    scopus 로고
    • Safety and tolerability of esome- prazole in children with gastroesophageal reflux disease
    • May
    • Gilger MA, Tolia V, Vandenplas Y, et al. Safety and tolerability of esome- prazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2008 May; 46 (5): 524-33.
    • (2008) J Pediatr Gastroenterol Nutr , vol.46 , Issue.5 , pp. 524-533
    • Gilger, M.A.1    Tolia, V.2    Vandenplas, Y.3
  • 16
    • 0034788746 scopus 로고    scopus 로고
    • Symptom relief in gastroesophageal reflux disease: A randomized, controlled comparison of pantoprazole and nizatidine in a mixed patient population with erosive esophagitis or endoscopy-negative reflux disease
    • DOI 10.1016/S0002-9270(01)02799-X, PII S000292700102799X
    • Armstrong D, Pare P, Pericak D, et al. Symptom relief in gastroesophageal reflux disease: a randomized, controlled comparison of pantoprazole and nizatidine in a mixed patient population with erosive esophagitis or endoscopy-negative reflux disease. Am J Gastroenterol 2001; 96 (10): 2849-57. (Pubitemid 32959523)
    • (2001) American Journal of Gastroenterology , vol.96 , Issue.10 , pp. 2849-2857
    • Armstrong, D.1    Pare, P.2    Pericak, D.3    Pyzyk, M.4
  • 17
    • 34250837382 scopus 로고    scopus 로고
    • Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis
    • DOI 10.1111/j.1365-2036.2007.03375.x
    • Hogan D, Pratha V, Riff D, et al. Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis. Aliment Pharmacol Ther 2007; 26 (2): 249-56. (Pubitemid 46985503)
    • (2007) Alimentary Pharmacology and Therapeutics , vol.26 , Issue.2 , pp. 249-256
    • Hogan, D.1    Pratha, V.2    Riff, D.3    Ducker, S.4    Schwartz, H.5    Soffer, E.6    Wang, W.7    Rath, N.8    Comer, G.M.9
  • 19
    • 70449651979 scopus 로고    scopus 로고
    • Bioequivalence study of pantoprazole granules administered to healthy subjects: Oral administration with applesauce and apple juice and by nasogastric tube
    • Tammara B, Weisel K, Katz A, et al. Bioequivalence study of pantoprazole granules administered to healthy subjects: oral administration with applesauce and apple juice and by nasogastric tube. Am J Health Syst Pharm 2009; 66: 1923-8.
    • (2009) Am J Health Syst Pharm , vol.66 , pp. 1923-8
    • Tammara, B.1    Weisel, K.2    Katz, A.3
  • 20
    • 79960161590 scopus 로고    scopus 로고
    • Bioavailability of the new pan- toprazole spheroid formulation to the currently marketed tablet formulation in healthy adult subjects [abstract no. 275]
    • [online] [Accessed 2011 Apr 27]
    • Tammara B, Orczyk G, Nightingale C, et al. Bioavailability of the new pan- toprazole spheroid formulation to the currently marketed tablet formulation in healthy adult subjects [abstract no. 275]. AAPS J 2004; 6 (Suppl. 1) [online]. Available from URL: http://www.aapsj.org/abstracts/AM-2004/AAPS2004- 000275.PDF [Accessed 2011 Apr 27].
    • (2004) AAPS J , vol.6 , Issue.SUPPL. 1
    • Tammara, B.1    Orczyk, G.2    Nightingale, C.3
  • 23
    • 0035016127 scopus 로고    scopus 로고
    • Pharmacogenetics and pharmacogenomics
    • Leeder J. Pharmacogenetics and pharmacogenomics. Pediatr Clin North Am 2001; 48: 765-81. (Pubitemid 32521715)
    • (2001) Pediatric Clinics of North America , vol.48 , Issue.3 , pp. 765-781
    • Leeder, J.S.1
  • 25
    • 79960201346 scopus 로고    scopus 로고
    • Pharmacodynamics (PD) and safety of pantoprazole delayed-release granules in infants aged 1 through 11 months with a clinical diagnosis of gastroesophageal reflux disease (GERD)
    • Comer G, Kierkus J, Sullivan J, et al. Pharmacodynamics (PD) and safety of pantoprazole delayed-release granules in infants aged 1 through 11 months with a clinical diagnosis of gastroesophageal reflux disease (GERD). Gastroenterology 2009; 136 (5 Suppl. 1): A-443-4.
    • (2009) Gastroenterology , vol.136 , Issue.5 SUPPL. 1
    • Comer, G.1    Kierkus, J.2    Sullivan, J.3
  • 26
    • 77955563166 scopus 로고    scopus 로고
    • Pharmacokinetics of two dose levels of pantoprazole sodium granules and tablets in children aged 1 through 11 years with endoscopically proven GERD [abstract no. 1348]
    • Tammara B,AdcockK, Kearns G,et al. Pharmacokinetics of two dose levels of pantoprazole sodium granules and tablets in children aged 1 through 11 years with endoscopically proven GERD [abstract no. 1348]. Am J Gastroenterol 2008; 103 (Suppl. 1): S528-9.
    • (2008) Am J Gastroenterol , vol.103 , Issue.SUPPL. 1
    • Tammara, B.1    Adcock, K.2    Kearns, G.3
  • 27
    • 77955485374 scopus 로고    scopus 로고
    • Pharmacokinetics of intravenous pantoprazole in children ages 1 to 16 years [abstract no. 1023]
    • Comer G, Tammara B, Adcock K, et al. Pharmacokinetics of intravenous pantoprazole in children ages 1 to 16 years [abstract no. 1023]. Am J Gas-troenterol 2005; 100 (Suppl. 9s): s373.
    • (2005) Am J Gas-troenterol , vol.100 , Issue.SUPPL. 9S
    • Comer, G.1    Tammara, B.2    Adcock, K.3
  • 28
    • 54049123804 scopus 로고    scopus 로고
    • Single-dose pharmacokinetics of oral and intravenous pantoprazole in children and adolescents
    • Kearns GL, Blumer J, Schexnayder S, et al. Single-dose pharmacokinetics of oral and intravenous pantoprazole in children and adolescents. J Clin Pharmacol 2008; 48 (11): 1356-65.
    • (2008) J Clin Pharmacol , vol.48 , Issue.11 , pp. 1356-1365
    • Kearns, G.L.1    Blumer, J.2    Schexnayder, S.3
  • 29
    • 41149180911 scopus 로고    scopus 로고
    • Mechanism-based concepts of size and maturity in pharmacokinetics
    • DOI 10.1146/annurev.pharmtox.48.113006.094708
    • Anderson BJ, Holford NH. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol 2008; 48: 303-32. (Pubitemid 351738156)
    • (2008) Annual Review of Pharmacology and Toxicology , vol.48 , pp. 303-332
    • Anderson, B.J.1    Holford, N.H.G.2
  • 30
    • 0036156595 scopus 로고    scopus 로고
    • The ontogeny of human drug-metabolizing enzymes: Phase I oxidative enzymes
    • DOI 10.1124/jpet.300.2.355
    • Hines RN, McCarver DG. The ontogeny of human drug-metabolizing en- zymes: phase I oxidative enzymes. J Pharmacol Exp Ther 2002; 300: 355-60. (Pubitemid 34106223)
    • (2002) Journal of Pharmacology and Experimental Therapeutics , vol.300 , Issue.2 , pp. 355-360
    • Hines, R.N.1    McCarver, D.G.2
  • 31
    • 77955563166 scopus 로고    scopus 로고
    • Pharmacokinetics of single and multiple doses of pantoprazole in adolescents with GERD [abstract no. 1347]
    • Tammara B, Ward R, Kearns G, et al. Pharmacokinetics of single and multiple doses of pantoprazole in adolescents with GERD [abstract no. 1347]. Am J Gastroenterol 2008; 103 (Suppl. 1): S528
    • (2008) Am J Gastroenterol , vol.103 , Issue.SUPPL. 1
    • Tammara, B.1    Ward, R.2    Kearns, G.3
  • 32
    • 77149130496 scopus 로고    scopus 로고
    • Dosing in children
    • Holford N. Dosing in children. Clin Pharmacol Ther 2010; 87 (3): 367-70
    • (2010) Clin Pharmacol Ther , vol.87 , Issue.3 , pp. 367-370
    • Holford, N.1
  • 33
    • 28944450056 scopus 로고    scopus 로고
    • Review article: Similarities and differences among delayed-release proton-pump inhibitor formulations
    • Horn JR, Howden CW. Review article: similarities and differences among delayed-release proton-pump inhibitor formulations. Aliment Pharmacol Ther 2005; 22 (Suppl. 3): 20-4. (Pubitemid 41783983)
    • (2005) Alimentary Pharmacology and Therapeutics, Supplement , vol.22 , Issue.3 , pp. 20-24
    • Horn, J.R.1    Howden, C.W.2
  • 34
    • 0033759927 scopus 로고    scopus 로고
    • Pharmacokinetics of orally ad- ministered omeprazole in children
    • Andersson T, Hassall E, Lundborg P, et al. Pharmacokinetics of orally ad- ministered omeprazole in children. Am J Gastroenterol 2000; 95 (11): 3101-6.
    • (2000) Am J Gastroenterol , vol.95 , Issue.11 , pp. 3101-6
    • Andersson, T.1    Hassall, E.2    Lundborg, P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.