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Completed

NCT Number: NCT00366938

Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).

This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, 07936, United States

Who can participate

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

Inclusion criteria

  • Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
  • Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion criteria

  • Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
  • Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Lumiracoxib

Drug

Primary outcomes

  1. Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.

  2. Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.

  3. Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.

Secondary outcomes

  1. Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.

  2. Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

  3. Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.

  4. Patient's health status using the Short Form-36 (SF-36), at week 13.

  5. Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Important dates

Study start
2003
Primary completion
2004
First posted
Aug 22, 2006
Registry last updated
May 21, 2012

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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