Efficacy and Safety of Lumiracoxib

Novartis330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

330

Conditions

Osteoarthritis

Interventions

LumiracoxibDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis

Nuremberg, Germany

Outcomes

Primary Outcomes

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 Outcomes

Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.