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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  11/21/2007
 
Trade Name:  Omnaris Nasal Spray
 
Generic or Proper Name (*):  ciclesonide
 
Indications Studied:  Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age
 
Therapeutic Category:  Antihistamine
 
Ages Studied:  2-12 years
 
Study #:  1
 
Study Type:  Safety/Tolerability
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  125
 
No Centers:  3
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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