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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  04/12/2010
Trade Name:  Pancreaze
Generic or Proper Name (*):  pancrelipase
Indications Studied:  Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
Therapeutic Category:  Pancreatic enzyme
Ages Studied:  1-17 years old
Study #:  1
Study Type:  Efficacy/Safety/Tolerability
Study Design:  Single-Blind/Placebo
No Patients:  14
No Centers:  12
No Countries:  2