Safety of Lumiracoxib in Patients With Osteoarthritis

Novartis309 enrolled

Overview

This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

309

Conditions

Osteoarthritis

Interventions

lumiracoxibDEVICE

400 mg once daily, oral over 6 weeks

rofecoxibDRUG

25 mg, oral, daily over 6 weeks

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>=50 years old * Primary osteoarthritis in hip, hand, knee or spine for at least 3 month * Pain in the target joint of moderate intensity * Written informed consent Exclusion Criteria: * Secondary osteoarthritis * Active upper gastro intestinal tract ulceration * Inflammatory joint disease * Gout * Clinically significant hepatic or renal disease Other in and exclusion criteria may apply

Outcomes

Primary Outcomes

Incidence of at least one of seven predefined gastrointestinal adverse events

Time frame: 6 weeks

Data from ClinicalTrials.gov

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