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A RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ETORICOXIB 90 MG PER DAY, VS. SODIC DICLOFENACO 50 MG THREE TIMES A DAY IN PATIENTS WITH OSTEOARTHRITIS.

A RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ETORICOXIB 90 MG PER DAY, VS. SODIC DICLOFENACO 50 MG THREE TIMES A DAY IN PATIENTS WITH OSTEOARTHRITIS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-054-02
Enrollment
6
Registered
2002-08-19
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

Etoricoxib 90 mg Type of group
One tablet of Etoricoxib 90 mg. once a day and a diclofenac placebo. Safety and clinical efficacy data will be collected during the clinical visits in the evaluation, and in Months 1, 4, 8, and 12 of the therapy. Group name:Diclofenac sodium 50 mg Type of group
One tablet of Diclofenac sodium 50 mg. three times a day and a placebo tablet of etoricoxib 90 mg. Safety and clinical efficacy data will be collected during the clinical visits in the evaluation, and in Months 1, 4, 8, and 12 of the therapy.

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Patients who had a clinical diagnosis of osteoarthritis and who were to require, as expected, a chronic therapy with NSAIDs or a selective COX-2 inhibitor for at least 1 year were considered eligible to enter the study after signing. an informed consent.

Exclusion criteria

Exclusion criteria: -

Design outcomes

Primary

MeasureTime frame
Outcome name:Global Assessment of the Patients Disease Condition Measure:The Global Assessment of the Patients Disease Condition will be collected at each study visit for each patient. Timepoints:month 1, 4, 8 y 12—

Secondary

MeasureTime frame
Outcome name:Adverse experiences reported spontaneously (including related gastrointestinal experiences), physical exams, vital signs (blood pressure and heart rate), laboratory safety measurements (complete blood count (CSC), serum chemistry and urinalysis) and ECGs. Measure:drug safety Timepoints:month 1, 4, 8 y 12—

Countries

Peru

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)