Efficacy and Safety of Lumiracoxib

A One-week Multicenter, Multiple-dose, Randomized, Double-blind, Double-dummy, Parallel-group Comparison of the Analgesic Efficacy and Safety of Lumiracoxib (COX189), Celecoxib, and Placebo in the Treatment of Osteoarthritis of the Knee

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00267215

Enrollment

330

Registered

2005-12-20

Start date

2000-11-30

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

Lumiracoxib, osteoarthritis

Brief summary

This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.

Interventions

DRUGLumiracoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Inclusion criteria

* Osteoarthritis of the knee * Pain intensity at baseline of at least 50mm on a 100mm visual analog scale Other protocol-defined inclusion/

Exclusion criteria

may apply

Design outcomes

Primary

Measure	Time frame
Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid	—

Secondary

Measure	Time frame
Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib	—

Countries

Germany

Outcome results

None listed

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