Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
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
1 other identifier
interventional
1,312
14 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedMay 21, 2012
May 1, 2012
11 months
May 18, 2007
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (15)
Novartis Investigative Site
Malvern, Australia
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Prague, Czechia
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
Novartis Investigative Site
Rotorua, New Zealand
Novartis Investigative Site
Poznan, Poland
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Johannesburg, South Africa
Novartis Investigative Site
Seville, Spain
Novartis Investigative Site
Uppsala, Sweden
Novartis Investigative Site
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 21, 2007
Study Start
December 1, 2003
Primary Completion
November 1, 2004
Last Updated
May 21, 2012
Record last verified: 2012-05