None listed
Conditions
Interventions
MK-0966 25 mg Type of group
25 mg of MK-0966 daily for 52 weeks.
Group name:Naproxen 500 mg Type of group
500 mg of naproxen twice a day
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient was registered in Protocol 097 of MK-0966. • The patient met all the original inclusion criteria for the base study (Protocol 097) • The patient completed the base study. Parts I and n through Visit 12.0 (52 weeks in the treatment of the protocol). • The patient tolerated the study-based medication and, in the opinion of the investigator and clinical monitor, demonstrated that he had completed the study procedures and the study medication. • The patient understands the study procedures and agrees to participate in the extension study by signing the informed consent.
Exclusion criteria
Exclusion criteria: • The patient experienced and / or was discontinued from study therapy due to serious or clinically important or serious adverse experiences during the baseline study. • Any specific contraindication to chronic naproxen therapy • The patient will need any of the following concomitant medications: Warfarin, Ticlopidine, Misoprostol, NSAIDs corresponding to the study, Chronic corticosteroid therapy greater than the equivalent of 10 mg daily of prednisone, aspirin in low doses that exceed 81 mg / day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events will be recorded in each exam on the Adverse Event Case Report Forms. Measure:Safety Timepoints:During the whole study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Global Patient Assessment of Pain (VAS) Global Assessment of the Patient on the Activity of the Disease (VAS) Global Researchers Assessment of Disease Activity (Likert) Health Assessment Questionnaire (HAQ) Measure:Efficacy Timepoints:The Likert and VAS scale will be recorded in Visits 14.0 to 18.0 and in the discontinuation visit (if the patient discontinues the study). The patient will respond to the Stanford Health Assessment Questionnaire (HAQ) on Visits 16.0 and 18.0 (or the discontinuation visit). | — |
Outcome results
None listed