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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  11/12/2009
 
Trade Name:  Protonix
 
Generic or Proper Name (*):  pantoprazole
 
Indications Studied:  GERD
 
Therapeutic Category:  Antiulcerative
 
Ages Studied:  0-16 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic/Pharmacodynamic
 
Study Design:  Open label/Population Pharmacokinetic
 
No Patients:  59
 
No Centers:  9
 
No Countries:  3
 
BPCA(B), PREA(P):  B, P
 
Asian:  1
 
Black:  9
 
Other:  3
 
White:  46
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  2
 
Non-Hispanic/Non Latino:  57
 
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