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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2004

Interventions

  • Drug: Lumiracoxib

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Overall OA pain intensity (Target knee) 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor

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