None listed
Conditions
Interventions
MK-0663 TREATMENT Type of group
Patients will take a daily dose of 90 mg of MK-0663, 120 mg of MK-0663 double-blind, triple-simulated.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a.The patient was enrolled in Protocol 010-00 of MK-0663 and in the first extension. b.The patient fulfilled all the original inclusion criteria for Protocol 010-00 and the first extension. c. The patient completed Protocol 010-00 and the first extension until Visit 17.0 (104 weeks with the protocol treatment). d.The patient tolerated the study medication and, in the opinion of the researcher and the clinical monitor, demonstrated that he had complied with the study procedures and medication. e.The patient understands the study procedures and agrees to participate in the study by signing the informed consent. f.At Visit 19.0, patients of childbearing age must demonstrate that they have a level of P-HCG in urine that is consistent with a non-pregnant state and must agree to abstain or use the double barrier contraception method.
Exclusion criteria
Exclusion criteria: a.The patient had and / or was withdrawn from study therapy due to serious or clinically important adverse experiences during Protocol 010-00 or the first extension. b.Some specific contraindication to permanent therapy with diclofenac. c. c. The patient will require any of the following concomitant medications: Warfarin, Misoprostol, Sucralfate, Digoxin, Ticlopidine, Clopidogrel, Aspirin (> 100 mg / day), Some ACME or specific COX-2 inhibitor that is not included in the study, Permanent therapy with corticosteroids in an amount greater than the equivalent of 10 mg daily of prednisone, continuous use (any period greater than 6 consecutive days) of H2 blockers (cimetidine, ranitidine, famotidine, nizatidine), antacids, or proton pump inhibitors in doses Prescribed or in doses without medical prescription.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical examination, vital signs, weight, blood biochemistry, blood cell count, urinalysis, electrocardiogram and P-HCG in urine. Measure:Safety Timepoints:During the control visits and at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The assessment of pain by the patient, the evaluation of the disease activity on the part of the patient and the global evaluation of the activity of the disease by the researcher. Discontinuations caused by lack of efficacy will serve as a secondary endpoint. Patients will respond to the HAQ disability scales Measure:Efficacy Timepoints:Health Assessment Questionnaire in Weeks 34 and 70 of the Second Extension (Visits 21.0 and 23.0). | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed