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Completed

NCT Number: NCT00476034

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

This 39-week, active controlled, 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 CCOX189A2361 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, Malvern, Australia

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.

Exclusion criteria

  • Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
  • Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Lumiracoxib

Drug

Primary outcomes

  1. To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:

  2. Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.

  3. Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.

  4. Patient's functional status using the WOMAC total score at 26 weeks

Secondary outcomes

  1. To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib

  2. To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:

  3. Overall OA pain intensity on a 0-100 mm VAS by visit

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

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

  6. Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit

  7. Usage of rescue medication

  8. Response to treatment according to OARSI criteria by visit

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 39-week, Double-blind, Active-controlled Extension to CCOX189A2361, 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
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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