None listed
Conditions
Interventions
6 to 11 years-old Type of group
At least 3 patient´s will be included in the group of 6 to 11 years. The study medicinewill be administered once a day, based on the patients weight:
• 30 to 40 kg (66 to 88 Ibs): 4 mL
• of 20 kg (44 Ibs): 3 mL
• of 10 kg (22 Ibs): 2 mL
Group name:Historic control group Type of group
A control group of adult subjects was selected and obtained by combining the data from the Steady-Stale Dose Proportionality Study (Protocol 042 [25-mg dose, Formulation C], 14 subjects), and the Dose Proportionality Formulation C Study (Protocol 043 [25-mg dose], 12 subjects).
Sponsors
MERCK SHARP & DOHME PERÚ S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Patient is age 2 to 11 years. b. If patient is in the 6- to 11-year-old group, he or she is of Tanner Stage 1. 2, or 3 (Appendix 1). c. Patient carries a diagnosis of pauci (oligo)- or polyarticular JRA (JRA), without active systemic symptoms (for the past 3 months), based on diagnostic criteria listed in Appendix 2. d. Parent or guardian gives informed consent to the patient´s participation in the study program. e. Patient is judged to be in otherwise good health on the basis of medical history, physical examination, and routine laboratory data (Appendices 3 and 4). f. Patient is neither grossly over- nor underweight for his/her age, being within the 5th to 95th percentile of weight for height.
Exclusion criteria
Exclusion criteria: a. Patient is under 2 or over 11 years of age. b. Patient weighs less than 10 kg (22 Ibs) or over 40 kg (88 Ibs). c. Patient is Tanner Stage 4 or 5. d. The patient is, in the opinion of the investigator, mentally incapacitated. e. Patient is in a situation (e.g., unreliable foster care) or has a condition which, in the investigator´s opinion, may interfere with optimal participation in the study. f. Patient has not resolved all symptoms and signs of an acute systemic infection at least 3 weeks prior to the pre-study visit. g. Patient has a history of clinically significant disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, genitourinary, or hematologic systems, or has chronic hypertension. h. Patient has had surgery or participated in another clinical trial within the last 4 weeks. i. Patient is allergic to acetaminophen/paracetamol, or has hypersensitivity (e.g., angioedema and/or bronchoconstriction) to aspirin and/or NSAIDs. j. Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering MK-0966 to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Steady-state MK-0966 AUC will be calculated using a 1 compartment model for all groups. Measure:AUC [0-24 hr], of MK-0966 in steady state Timepoints:On Day 13, multiple blood samples will be taken before and after the dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Plasma determination of drug Cmax Measure:Cmax Timepoints:On Day 13, multiple blood samples will be taken before and after the dose. ; Outcome name:Plasma determination of drug Tmax Measure:Tmax Timepoints:On Day 13, multiple blood samples will be taken before and after the dose. ; Outcome name:Efficacy measurements used in this protocol derive from a core set of variables developed for defining disease improvement in juvenile arthritis. The core set is as Listed. 1. Investigator´s global assessment of disease activity 2. Patient/parent´s assessment of overall well being 3. Functional ability 4. Number of joints with active arthritis 5. Number of joints with limited range of motion 6. C-reactive protein level Measure:Core set of variables Timepoints:Data for core set components will be collected at Visits 1.0 and 2.0 (or Discontinuation) | — |
Contacts
Public ContactStela López
MERCK SHARP & DOHME PERÚ S.R.L
Outcome results
None listed