Clinical trial NCT00476034: Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
lumiracoxib
celecoxib
Cox-2
knee
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 1312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
measure: Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
measure: Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
measure: Patient's functional status using the WOMAC total score at 26 weeks
Secondary outcomes:
measure: To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
measure: To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
measure: Overall OA pain intensity on a 0-100 mm VAS by visit
measure: Patient's global assessment of disease activity by visit
measure: Physician's global assessment of disease activity by visit
measure: Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
measure: Usage of rescue medication
measure: Response to treatment according to OARSI criteria by visit
Other outcomes:
Locations:
city: Malvern
country: Australia
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Prague
country: Czech Republic
facility: Novartis Investigative Site
city: Turku
country: Finland
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Lisse
country: Netherlands
facility: Novartis Investigative Site
city: Rotorua
country: New Zealand
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Johannesburg
country: South Africa
facility: Novartis Investigative Site
city: Sevilla
country: Spain
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
References: