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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00476034

Enrollment

1312

Registered

2007-05-21

Start date

2003-12-31

Completion date

Unknown

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee

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.

Interventions

DRUGlumiracoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—
To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib	—
Response to treatment according to OARSI criteria by visit	—
Usage of rescue medication	—
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	—

Countries

Australia, Austria, Czechia, Finland, Germany, Hungary, Israel, Netherlands, New Zealand, Poland, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026