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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/15/2011
 
Trade Name:  Nexium
 
Generic or Proper Name (*):  esomeprazole
 
Indications Studied:  Erosive esophagitis due to acid-mediated gastroesophageal reflux disease
 
Therapeutic Category:  Antiulcerative
 
Ages Studied:  0 - < 44 weeks
 
Study #:  3
 
Study Type:  Pharmacokinetic/Pharmacodynamic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  26
 
No Centers:  1
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Unknown:  0
 
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