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

Phase 3

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00476034
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2004-11
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Physician's global assessment of disease activity by visit
To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
Usage of rescue medication
Response to treatment according to OARSI criteria by visit

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Izmir, Turkey