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DOUBLE-BLIND, ONE YEAR PARALLEL GROUPS STUDY CONTROLLED WITH ACTIVE COMPARATOR AND CARRIED OUT IN BLIND CONDITIONS TO EVALUATE THE SAFETY AND EFFICACY OF MK-966 (L-748, 731) IN PURCHASE WITH SODIUM DICLOFENACO IN PATIENTS WITH KNEE AND HIP OSTEOARTHRITIS

DOUBLE-BLIND, ONE YEAR PARALLEL GROUPS STUDY CONTROLLED WITH ACTIVE COMPARATOR AND CARRIED OUT IN BLIND CONDITIONS TO EVALUATE THE SAFETY AND EFFICACY OF MK-966 (L-748, 731) IN PURCHASE WITH SODIUM DICLOFENACO IN PATIENTS WITH KNEE AND HIP OSTEOARTHRITIS

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-044-99
Enrollment
36
Registered
1999-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

MK-0966 12.5 mg Type of group
MK-0966 12.5 mg orally once daily for a year Group name:Diclofenac Type of group
diclofenac 50 mg orally three times daily for a year

Sponsors

MERCK SHARP & DOHME PERÚ S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patient completed Protocol 034-10 per-protocol through Visit 19.0 (Treatment Week 104). • Patient tolerated Protocol 034-10 study medication, and, in the opinion of the investigator and clinical monitor, demonstrated compliance with study procedures and study medication. • Patient understands the study procedures and agrees to participate in the study by signing the informed consent document. • Female patients of childbearing potential must demonstrate a urine (3-hCG level consistent with a nongravid state at Visit 19.0/21.0 and agree to remain abstinent or use oral contraceptives or use double-barrier contraception (partner using condom and patient using diaphragm, contraceptive sponge, or lUD) throughout the study and continuing at least 14 days after completion of treatment with study medication.

Exclusion criteria

Exclusion criteria: Patient experienced and/or was withdrawn from the study because of serious or clinically important adverse experiences during Protocol 034-10 as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Outcome name:Safety will be monitored by repeated vital signs, physical examinations, and safety laboratory values. Female patients of childbearing potential also will be monitored by measuring urine b-hCG. Patient and investigator global evaluations and WOMAC VA 3.0, Section A., Question 1, (assessment of pain walking on a flat surface) will be solicited throughout the study as an indication of the patients overall clinical status. A radiograph of the study joint will be performed at treatment Week 156 or discontinuation from the study. Measure:Safety Timepoints:Duration of the Study—

Contacts

Public ContactStela López

MERCK SHARP & DOHME PERÚ S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)