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

NCT00269191 | Completed Phase 3

• 2 other identifiers: 0663-0712005_110
• Study Type: interventional
• Target: 528
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

Arcoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

MK0663, etoricoxib / Duration of Treatment 12 Weeks DRUG

Placebo or Ibuprofen / Duration of Treatment 12 Weeks DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (2)

• Wiesenhutter CW, Boice JA, Ko A, Sheldon EA, Murphy FT, Wittmer BA, Aversano ML, Reicin AS; Protocol 071 Study Group. Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005 Apr;80(4):470-9. doi: 10.4065/80.4.470.

  PMID: 15819283 BACKGROUND

• Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP; MEDAL Steering Committee. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2007 Feb 10;369(9560):465-73. doi: 10.1016/S0140-6736(07)60234-7.

  PMID: 17292766 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Etoricoxib; Duration of Therapy; Ibuprofen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 23, 2005
• Study Start: February 5, 2003
• Primary Completion: November 7, 2003
• Study Completion: November 21, 2003
• Last Updated: August 15, 2024

Record last verified: 2022-02