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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: May 18, 2007
Last updated: May 18, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Osteoarthritis Drug: lumiracoxib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
  • Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
  • Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
  • Patient's functional status using the WOMAC total score at 26 weeks

Secondary Outcome Measures:
  • To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
  • To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
  • Overall OA pain intensity on a 0-100 mm VAS by visit
  • Patient's global assessment of disease activity by visit
  • Physician's global assessment of disease activity by visit
  • Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
  • Usage of rescue medication
  • Response to treatment according to OARSI criteria by visit

Enrollment: 1312
Study Start Date: December 2003
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00476034

Novartis Investigative Site
Malvern, Australia
Novartis Investigative Site
Vienna, Austria
Czech Republic
Novartis Investigative Site
Prague, Czech Republic
Novartis Investigative Site
Turku, Finland
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Lisse, Netherlands
New Zealand
Novartis Investigative Site
Rotorua, New Zealand
Novartis Investigative Site
Poznan, Poland
Novartis Investigative Site
Bratislava, Slovakia
South Africa
Novartis Investigative Site
Johannesburg, South Africa
Novartis Investigative Site
Sevilla, Spain
Novartis Investigative Site
Uppsala, Sweden
Novartis Investigative Site
Izmir, Turkey
Sponsors and Collaborators
  More Information

Responsible Party: Novartis Identifier: NCT00476034     History of Changes
Other Study ID Numbers: CCOX189A2361E1
Study First Received: May 18, 2007
Last Updated: May 18, 2012

Keywords provided by Novartis:

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on August 17, 2017