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

May 18, 2012 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1312

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Response to treatment according to OARSI criteria by visit
Usage of rescue medication
Patient's global assessment of disease activity by visit
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOX189A2361E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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