None listed
Conditions
Interventions
Low dose of rofecoxib Type of group
0.35 mg / kg / day in patients from 2 to 11 years of age (without exceeding 12.5 mg / day) OR 12.5 mg per day for patients 12 to 17 years old
Group name:Naproxen Type of group
15 / mg / kg / day. Patients from 2 to 11 years of age will receive formulations in suspension and those from 12 to 17 years will be given tablets.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patient from 2 to 17 years old. • Patient with a diagnosis of polyarticular JRA or pauci (oligo) articular without active systemic symptoms (during the last 3 months) based on the diagnostic criteria mentioned in Appendix 1. • Patient with a diagnosis of ARJ of at least 3 months. • At the screening visit (Visit 1.0), the patient / parent assessment of overall well-being (EVA 100 mm) is 10 mm. • Patient with at least 3 active joints at the time of the appointment (Visit 2.0). • Girls of menarche age with a negative pregnancy test on serum P-HCG within 14 days prior to the treatment period. If they are sexually active, girls should use an acceptable contraceptive method (eg, oral contraceptives) from 2 weeks before treatment to 2 weeks after the study ends. • The parents or guardians and the patient agree that the patient participates in the indicated study program by means of! permission and consent (as appropriate) of the parents respectively. The patient wishes to comply with the study procedures and can attend scheduled clinic visits. • The patient is considered to be in good health based on the medical history, physical examination and routine laboratory tests • The patient is not overweight or underweight according to age, being between the 5th to 95th percentile of the weight according to height.
Exclusion criteria
Exclusion criteria: • Patient under 2 years of age or who will turn 18 before the end of the treatment period. • The patient is, in the opinion of the researcher, mentally incapacitated. • 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 an adequate contraceptive method or remain abstinent during the study. • Patient in whom all the symptoms and signs of an acute systemic infection have not been resolved at least 2 weeks before the pre-study visit. • Patient with a history of a clinically significant disease of the gastrointestinal system (eg, active peptic ulcer or inflammatory bowel disease), cardiovascular, hepatic (Child-Pugh score 27), neurological, renal, genitourinary or hematologic or with chronic hypertension . • Patient with estimated creatinine clearance 90 mm at the screening visit (Visit 1.0) and 0.2 mg / kg / day of prednisone, without exc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation by the Patient or Parents of Global Wellbeing Measure:Global Wellbeing Timepoints:In the pre-study visit and in all subsequent visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Researchers Global Assessment of the Disease Activity Measure:Disease Activity Timepoints:In the pre-study visit and in all subsequent visits. ; Outcome name:Patient assessment of functional capacity (CHAQ) Measure:Functional Capacity (CHAQ) Timepoints:In the pre-study visit and in all subsequent visits. ; Outcome name:Global Assessment by the Patient / Parents of Pain Measure:Pain Timepoints:In the pre-study visit and in all subsequent visits. ; Outcome name:Evaluation of the joints and the total of active joints Measure:Number of Joints with Active Arthritis Timepoints:Active articulations in visits 2 and 7 (post-study). Evaluation of joints in all visits. ; Outcome name:Evaluation of the joints Measure:Number of Joints with Limited Range of Mobility Timepoints:Evaluation of joints in all visits. ; Outcome name:Evaluation by the Patient or Parents of Global Wellbeing Measure:Proportion of patients who stopped treatment due to lack of efficacy Timepoints:In the pre-study visit and in all subsequent visits. ; Outcome name:Measurement of VSG Measure:VSG Timepoints:On visits 1, 2, 4, 5 y 7 | — |
Outcome results
None listed