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Study 195: ACR Pediatric 30 Response Double-Blind Phase by Age

Study 195: ACR Pediatric 30 Response Double-Blind Phase by Age. Week 12. N = 13 16 10 9 9 11 31 35 35 24 22 27. B21. Study 195: Summary of Adverse Events Double-Blind Phase by Age. B22. n/N (% of patients).

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Study 195: ACR Pediatric 30 Response Double-Blind Phase by Age

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  1. Study 195: ACR Pediatric 30 ResponseDouble-Blind Phase byAge Week 12 N = 13 16 10 9 9 11 31 35 35 24 22 27 B21

  2. Study 195: Summary of Adverse EventsDouble-Blind Phase by Age B22 n/N (% of patients)

  3. Study 195: Systolic BP at BaselineDouble-Blind Phase B114 Definitions based on Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents, 2004.

  4. Celecoxib 3 mg/kg BID (N=71) Celecoxib 6 mg/kg BID (N=77) Naproxen 7.5 mg/kg BID (N=80) Study 195: SBP Categories—Double-Blind PhaseIncrease from Baseline at Two Consecutive Visits Percentage of Patients No conversion to Stage 2 hypertension in any treatment group B115

  5. Study 195: Number of Joints with Active Arthritis—Change from Baseline LS Mean Change (SE) Week B168 Total joints = 73

  6. Study 195: Physician’s Global Assessment of Disease Activity—Change from Baseline LS Mean Change (SE) Week Scale = 1-100 mm A negative mean change indicates improvement in disease activity. B165

  7. Celecoxib Clearance from Study 195 JRA Patients (n=152) Adult RA Patients (n=36) C9

  8. Celecoxib: Pediatric Dosage Forms Evaluated • Orally disintegrating tablet • Difficulties in scaling up the manufacturing process • Pharmaceutical elegance is poor, e.g. appearance, issues with sticking • Chewable tablet • Initiated after orally disintegrated tablet • Conducted in parallel with suspension program • Discontinued after lack of bioequivalence (early technical batch) with capsule • Commercial technical feasibility unknown • Suspension • Difficulties in scaling up the manufacturing process due to robustness issues • Additional technical development activities necessary to address robustness • Discontinued in favor of sprinkle capsule C62

  9. Suspension Pharmaceutical Evaluation:Aggregate Size – Scanning Electron Microscopy K0300839 "as is“ – Returned Clinical Lot 38849-DLH-026 New Lab Scale 38849-DLH-022 (Lot K0300839 Homogenized) C64

  10. Study 195: Prior NSAID Use B599 Patients may have been taking more than one NSAID

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