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

Novartis833 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

833

Conditions

Osteoarthritis

Interventions

LumiracoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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/exclusion criteria may apply

Locations (6)

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Brooklyn Park, Minnesota, United States

Unnamed facility

Albuquerque, New Mexico, United States

Unnamed facility

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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