Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)

A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00242489

Enrollment

1167

Registered

2005-10-20

Start date

1998-06-30

Completion date

2002-07-31

Last updated

2022-02-18

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

The purpose of this study is to evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.

Interventions

DRUGMK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)

DRUGPlacebo;Diclofenac 50mg(tid)/Duration of Treatment: Part I (Placebo) 6 weeks;Part II (Diclofenac) 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III). * Positive therapeutic effect from prior NSAID therapy. * Worsening of symptoms upon withdrawal of prior treatment. * With the exception of OA, in otherwise good health

Exclusion criteria

* Weight no more than 280 pounds (male or female). * Recent, sustained use of gastroprotective agents. * History of arthroscopy of the affected knee within 6 months prior to study entry. * History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.

Design outcomes

Primary

Measure	Time frame
WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)	—

Secondary

Measure	Time frame
Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026