Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-