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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  03/20/2008
 
Trade Name:  Prilosec
 
Generic or Proper Name (*):  omeprazole
 
Indications Studied:  Maintenance healing of erosive esophagitis
 
Therapeutic Category:  Antiulcerative
 
Ages Studied:  0-2 years
 
Study #:  2
 
Study Type:  Efficacy
 
Study Design:  Other
 
No Patients:  115
 
No Centers:  21
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  15
 
Other:  2
 
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