A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)

A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00269191

Enrollment

528

Registered

2005-12-23

Start date

2003-02-05

Completion date

2003-11-21

Last updated

2024-08-15

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

Conditions

Osteoarthritis

Keywords

Arcoxia

Brief summary

This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Interventions

DRUGMK0663, etoricoxib / Duration of Treatment 12 Weeks

DRUGPlacebo or Ibuprofen / Duration of Treatment 12 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee * Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III * Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment * Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.

Exclusion criteria

* No history of concurrent arthritic disease * uncontrolled hypertension or an active cardiac condition * No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.

Design outcomes

Primary

Measure	Time frame
Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.	—

Secondary

Measure	Time frame
Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026