Skip to main content
OpenTrials
Completed

NCT Number: NCT00269191

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK0663, etoricoxib / Duration of Treatment 12 Weeks

Drug

Placebo or Ibuprofen / Duration of Treatment 12 Weeks

Drug

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Dec 23, 2005
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.