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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  06/30/2008
 
Trade Name:  Aciphex
 
Generic or Proper Name (*):  rabeprazole
 
Indications Studied:  Gastroesophageal reflux in adolescent patients 12 years of age and above
 
Therapeutic Category:  Antiulcerative
 
Ages Studied:  12 years and older
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label
 
No Patients:  111
 
No Centers:  25
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  5
 
Other:  3
 
White:  100
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  3
 
Non-Hispanic/Non Latino:  0
 
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