A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED)

A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092365

Enrollment

413

Registered

2004-09-27

Start date

2003-04-01

Completion date

2003-11-01

Last updated

2017-05-09

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

Conditions

Osteoarthritis

Brief summary

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of osteoarthritis of the knee.

Detailed description

The duration of treatment is 6 weeks.

Interventions

DRUGMK0966, rofecoxib

DRUGComparator: celecoxib, placebo

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

* Osteoarthritis of the knee which requires treatment with medication for pain relief

Exclusion criteria

* Any known allergy to the study drugs

Design outcomes

Primary

Measure	Time frame
Osteoarthritis (OA) of the knee as measured by Patient Global Assessment of Response to Therapy (PGART) and WOMAC VA 3.0 over 6 weeks of treatment.	—

Secondary

Measure	Time frame
OA of the knee as measured by PGART over 6 wks of treatment.	—
WOMAC Question #1 over 6 wks of treatment.	—

Outcome results

None listed

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