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OpenTrials
Completed

NCT Number: NCT00542087

Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

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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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is at least 40 years old and diagnosed with osteoarthritis of the knee or hip
  • Has a history of treatment with NSAIDs with positive therapeutic benefit
  • Agree to limit alcohol intake to less than 7 drinks per week and avoid unusual strenuous activity
  • Females who are able to have children must have negative urine pregnancy tests

Exclusion criteria

  • Has rheumatoid arthritis, lupus, Paget's disease affecting the study joint, or Wilson's disease
  • History of acute ligament or meniscus damage to the study joint (knee or hip) within the past 2 years or arthroscopic surgery on the affected study joint with the past 6 months
  • Requires joint replacement

Treatment and study plan

MK0663, etoricoxib / Duration of Treatment: 6 Weeks

Drug

Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks

Drug

Primary outcomes

  1. This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

Secondary outcomes

  1. The study drug will be safe and well tolerated during the course of the study.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Oct 10, 2007
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.

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