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OpenTrials
Completed

NCT Number: NCT00475800

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

This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Brampton, Ontario, Canada

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Who can participate

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

Inclusion criteria

  • Have completed the core CCOX189A2360 study
  • Males and females over the 18 years old

Exclusion criteria

  • Treatment in the extension study is not considered appropriate by the treating physician
  • Non-compliance or major protocol violation of the core study

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Lumiracoxib

Drug

Primary outcomes

  1. To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.

Secondary outcomes

  1. Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit

  2. Patient's global assessment of disease activity by visit

  3. Physician's global assessment of disease activity by visit.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 39-week, Open-label Extension to CCOX189A2360, 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
2004
Primary completion
2004
First posted
May 21, 2007
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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