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Completed

NCT Number: NCT00242489

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

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

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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 2

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

MK0663, etoricoxib / Duration of Treatment: Part I (6 weeks), Part II (8 weeks)

Drug

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

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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.

Important dates

Study start
1998
Primary completion
1999
Study completion
2002
First posted
Oct 20, 2005
Registry last updated
Feb 18, 2022

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.

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