None listed
Conditions
Interventions
2 to 11 years old Type of group
Rofecoxib 0.7 mg / kg / day taken as 0.14 ml / kg once a day in a suspension of 5.0 mg / mL or naproxen with initial dose of 15 mg / kg / day, taken as 0.3 mU / kg twice a day in a suspension of 25 mg / mL.
Group name:12 to 17 years old Type of group
25 mg of rofecoxib (taken in a tablet once a day) or naproxen 375 or 500 mg twice a day to approximate as much as possible to a total daily dose of 15 mg / kg.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patient who has completed the 12-week base study without having presented significant protocol violations and without an important clinical contraindication to continue with the study treatment. • Girls of menarche age should continue with a negative pregnancy test in p-HCG and, if sexually active, use an acceptable contraceptive method (eg, oral contraceptives) up to 2 weeks after the end of the study. • The parents or guardians and the patient agree that the patient participates in the indicated extension study program through informed consent. The patient wishes to comply with the study procedures and can attend the scheduled clinic visits. • It is considered that the patient continues to be in good health, with the exception of the underlying JRA, based on the medical history, physical examination and routine laboratory tests.
Exclusion criteria
Exclusion criteria: • The patient was assigned inappropriately in the base study. • The patient had a significant violation of the protocol in the base study. • The patient has a significant clinical contraindication to continue with the study medication. (See Appendix 1, product circulars for naproxen and rofecoxib). • The patient is in a situation (for example, unreliable nursing care) or suffers from a condition that, in the opinion of the investigator, may interfere with their optimal participation in the study. • Pregnant or breastfeeding patient or a sexually active child who does not want to use adequate contraception or remain abstinent during the study. • None of the following agents may be used during the study: Systemic salicylates, NSAIDs, or specific COX 2 inhibitors not belonging to the study during the treatment period. Exception: The use of low doses of acetylisalicylic acid is allowed up to 100 mg daily as antiplatelet therapy, if clinically indicated, Systemic corticosteroids at doses of> 0.2 mg / kg / day of prednisone, without exceeding a total dose of 10 mg, Alkylating agents, Anticonvulsants, Warfarin, Rifampicin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Analogue visual scale of 100 mm (EVA). This refers to how the patient is affected by his arthritis. Measure:Evaluation by the Patient / Parents of Global Wellbeing Timepoints:Filled weekly by the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Articular Examination Based on Articular Count. Joints will be scored as to: inflammation, direct pressure sensitivity and pain to passive manipulation through the full range of available mobility, range of mobility and number of active joints. Measure:Global Assessment by the Disease Activity Researcher Timepoints:6 months ; Outcome name:CHAQ Scales of discomfort and disability Measure:Functional capacity Timepoints:On visits 9. 10, 11 y 12 ; Outcome name:Individual counting of inflamed joints, painful / sensitive joints and in the evaluation of range of mobility. Measure:Number of Joints with Active Arthritis Timepoints:10th visit ; Outcome name:Individual counting of inflamed joints, painful / tender joints and in the evaluation of range of mobility Measure:Number of Joints with Limited Range of Mobility Timepoints:10th visit ; Outcome name:Analogue visual scale of 100 mm (EVA). Measure:Global Assessment by the Patient / Parents of Pain Timepoints:Filled weekly by the patient | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed