An Investigational Drug in Patients With Osteoarthritis (0663-073)

NCT ID: NCT00092755

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-09
• Study Completion Date: 2003-11-13

Brief Summary

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

Detailed Description

The duration of treatment is 12 weeks.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0663, etoricoxib

Intervention Type: DRUG

Comparators: ibuprofen and placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with osteoarthritis of the hip or knee who use current approved medication (nonsteroidal anti-inflammatory drugs (NSAIDs)) or tylenol to treat the symptoms of their osteoarthritis. Patients taking NSAIDs are required to discontinue using these drugs and their symptoms must become worse.

Exclusion Criteria

• Patients with certain medical conditions may not be allowed to participate. These conditions will be reviewed with the study physician.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Puopolo A, Boice JA, Fidelholtz JL, Littlejohn TW, Miranda P, Berrocal A, Ko A, Cichanowitz N, Reicin AS. A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Dec;15(12):1348-56. doi: 10.1016/j.joca.2007.05.022. Epub 2007 Jul 16.

Reference Type: BACKGROUND

PMID: 17631392 (View on PubMed)

Other Identifiers

2004_056

Identifier Type: -

Identifier Source: secondary_id

0663-073

Identifier Type: -

Identifier Source: org_study_id