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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00475800

Enrollment

833

Registered

2007-05-21

Start date

2004-01-31

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, 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.

Interventions

DRUGLumiracoxib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Canada, United States

Outcome results

None listed

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