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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/18/2009
 
Trade Name:  Nexium
 
Generic or Proper Name (*):  esomeprazole
 
Indications Studied:  Short-term treatment of GERD
 
Therapeutic Category:  Antiulcerative
 
Ages Studied:  0-11 months
 
Study #:  3
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  80
 
No Centers:  25
 
No Countries:  4
 
BPCA(B), PREA(P):  B, P
 
Asian:  2
 
Black:  2
 
Other:  4
 
White:  72
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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