# Presentation: 061905

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

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

**    ****N =  13   16  10             9     9   11            31   35  35            24   22   27**

**Week 12**

- B21

**Notes:**
T11.2.17.1.2, T11.2.17.2.2, T11.2.17.3.2, T11.2.17.4.2
QC

## Study 195:  Summary of Adverse Events Double-Blind Phase by Age

|  | Celecoxib 3 mg/kg BID
N=77 | Celecoxib 6 mg/kg BID
N=82 | Naproxen 7.5 mg/kg BID
N=83 |
| --- | --- | --- | --- |
| Any event | 49 (63.6) | 57 (69.5) | 60 (72.3) |
|    2-4 years | 10/13 (76.9) | 15/16 (93.9) | 6/10 (60.0) |
|    5-7 years | 6/9 (66.7) | 7/9 (77.8) | 6/11 (54.5) |
|    8-12 years | 20/31 (64.5) | 22/35 (62.9) | 30/35 (85.7) |
|    ≥13 years | 13/24 (54.2) | 13/22 (59.1) | 18/27 (66.7) |
| Withdrawals due to AE | 3 (3.9) | 7 (8.5) | 3 (3.6) |
|    2-4 years | 0/13 (0.0) | 3/16 (18.8) | 0/10 (0.0) |
|    5-7 years | 2/9 (22.2) | 1/9 (11.1) | 0/11 (0.0) |
|    8-12 years | 0/31 (0.0) | 2/35 (5.7) | 1/35 (2.9) |
|    ≥13 years | 1/24 (4.2) | 1/22 (4.5) | 2/27 (7.4) |
| Serious adverse events | 3 (3.9) | 2 (2.4) | 0 (0.0) |
|    5-7 years | Hepatitis CMV | Asthma  |  |
|    8-12 years | Viral infection  |  |  |
|    ≥13 years | Abdominal pain  | JRA |  |

**n/N (% of patients)**

- B22

**Notes:**
CSRTable T20.1
Post hoc tables T20.1.19.1, T20.1.19.2, T20.1.19.3, T20.1.19.4
T21.1.19.1, T21.1.19.2, T21.1.19.3, T21.1.19.4
QC

## Study 195:  Systolic BP at BaselineDouble-Blind Phase

**Definitions based on Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents, 2004. **

- B114

**Notes:**
Table 7.45, Pages 1-3
QC

## Study 195:  SBP Categories—Double-Blind PhaseIncrease from Baseline at Two Consecutive Visits

**Study 195:  SBP Categories—Double-Blind Phase****Increase from Baseline at Two Consecutive Visits**

**Percentage of Patients**

**No conversion to Stage 2 hypertension in any treatment group**

- B115

**Notes:**
Source: Pages 13-15 Table 7.45 (17Nov2006)
QC

## Study 195:  Number of Joints with Active Arthritis—Change from Baseline

**LS Mean Change (SE)**

**Week**

**Total joints = 73**

- B168

**Notes:**
CSR T8.3
QC

## Study 195:  Physician’s Global Assessment of Disease Activity—Change from Baseline 

**Scale = 1-100 mm**
**A negative mean change indicates improvement in disease activity.  **

**LS Mean Change (SE)**

**Week**

- B165

**Notes:**
CSR T5.3
QC

## Celecoxib Clearance from Study 195

**JRA Patients (n=152)**
**Adult RA Patients (n=36)**

- C9

## 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

## 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

## Study 195:  Prior NSAID Use 

|  | Celecoxib
3 mg/kg BIDN = 77  |  | Celecoxib
6 mg/kg BID
N = 82  |  | Naproxen
7.5 mg/kg BIDN = 83  |  |
| --- | --- | --- | --- | --- | --- | --- |
| NSAID use, N (%) | 45  | (58.4) | 47  | (57.3) | 47  | (56.6) |
| 	Naproxen | 22  | (28.6) | 24 | (29.3) | 25 | (30.1) |
|   Diclofenac | 5 | (6.5) | 10 | (12.2) | 9 | (10.8) |
|   Ibuprofen | 10 | (13.0) | 5 | (6.1) | 10 | (12.0) |
|   Nimesulide | 3 | (3.9) | 2 | (2.4) | 3 | (3.6) |
|   Rofecoxib | 2 | (2.6) | 2 | (2.4) | 0 | (0.0) |
|   Indomethacin | 0 | (0.0) | 3 | (3.7) | 0 | (0.0) |
|   Etodolac | 1 | (1.3) | 1 | (1.2) | 0 | (0.0) |
|   Piroxicam | 1 | (1.3) | 0 | (0.0) | 1 | (1.2) |
|   Ketoprofen | 1 | (1.3) | 0 | (0.0) | 0 | (0.0) |
|   Tolmetin | 0 | (0.0) | 1 | (1.2) | 0 | (0.0) |

**Patients may have been taking more than one NSAID**

- B599

**Notes:**
Source: Appendix 1—Prior and Baseline Medication Use (17Aug06)
QC