None listed
Conditions
Interventions
Group 1 Type of group
MK-0663 90 mg once per day for 69 weeks
Group name:Group 3 Type of group
Naproxen 500 mg twice a day for 69 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient was incorporated into Protocol 025 for MK-0663 (base protocol) and completed Parts I and II per protocol until Visit 11.0 (Treatment Week 52). Met all entry criteria of Protocol 025 for MK-0663 (base protocol). (Note: If the patient did not meet all the entry criteria but was included by a specific exception approved by Merck, it may also be incorporated in this extension). • The patient tolerated the base study medication, and in the opinion of the researcher, demonstrated compliance with the study´s procedures and medication. • The patient understands the study procedures and agrees to participate in the study by signing the informed consent document. • The female patient must demonstrate a b-hCG subunit level congruent with a non-pregnant status at Visit 11.0 / 13.0, and agree to abstain b on using a double-barrier method of contraception (couple uses condoms) and the patient´s diaphragm, contraceptive sponge, spermicide, or IUD) during the entire duration of the study, and continuing for at least 14 days after Visit 17.0 or a discontinuation visit. Post-menopausal women or women in a post-hysterectomy or tubal ligation condition are exempt from this requirement. (Postmenopausal is defined as without menstruation during the last previous year.If the termination of menstruation is within 12 months prior to visit 11.0, the level of FSH raised to the postmenopausal range should be documented in the pre-study).
Exclusion criteria
Exclusion criteria: • The patient experienced and / or was withdrawn from the study due to serious or clinically important adverse experiences during Part I and II of the base protocol, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Control of adverse experiences, Health Assessment Questionnaire (HAQ), Overall evaluation of the patient on the activity of the disease Measure:Safety and Tolerability Timepoints:Control of adverse experiences at weeks 1, 17, 34, 52, 69. Health Assessment Questionnaire (HAQ) and Overall evaluation of the patient on the activity of the disease at 69 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Overall evaluation of the patient about the activity of the disease, Overall assessment of the patient on pain, Health Assessment Questionnaire (HAQ), Global evaluation of the researcher on the activity of the disease Measure:Therapeutic Response Timepoints:Week 69 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed