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

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

NCT00366938

Enrollment

1464

Registered

2006-08-22

Start date

2003-09-30

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, Knee

Keywords

Osteoarthritis, lumiracoxib, celecoxib, Cox-2

Brief summary

This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).

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

* Primary osteoarthritis of knee (confirmed by American College of Rheumatology \[ACR\] criteria). * Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion criteria

* Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years. * Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib). Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.	—
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.	—
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.	—

Secondary

Measure	Time frame
Patient's health status using the Short Form-36 (SF-36), at week 13.	—
Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.	—
Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.	—
Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.	—
Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.	—

Countries

United States

Outcome results

None listed

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