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

Novartis1,684 enrolled

Overview

This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,684

Conditions

Knee Osteoarthritis

Interventions

LumiracoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 peptic 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/exclusion criteria may apply

Locations (2)

Novartis

Nuremberg, Germany

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.

Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.

Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.

Secondary Outcomes

• Overall OA pain intensity in the target knee 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 health status using the Short Form-36 (SF-36), at week 13.

Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Data from ClinicalTrials.gov

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