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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-05

Study Completion Date

2003-11-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0663, etoricoxib / Duration of Treatment 12 Weeks

Intervention Type DRUG

Placebo or Ibuprofen / Duration of Treatment 12 Weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No