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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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Approval Date:
10/28/2008
Trade Name:
Prevacid
Generic or Proper Name (*):
lansoprazole
Indications Studied:
Symptomatic GERD in infants
Therapeutic Category:
Antiulcerative
Ages Studied:
0-11 months
Study #:
1
Study Type:
Efficacy/Safety/Pharmacokinetic
Study Design:
Single-Blind/Placebo/Parallel Group Traditional Pharmacokinetic/Pharmacodynamic
No Patients:
162
No Centers:
8
No Countries:
2
BPCA(B), PREA(P):
B, P
Asian:
1
Black:
27
Other:
5
White:
129
Native Hawaiian or Pacific Islander:
0
American Indian/Alaska Native:
0
Hispanic/Latino:
0
Non-Hispanic/Non Latino:
0
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