Safety of Lumiracoxib in Patients With Osteoarthritis

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

Completed

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumiracoxib

Device

400 mg once daily, oral over 6 weeks

Other names: Prexige

Rofecoxib

Drug

25 mg, oral, daily over 6 weeks

Other names: Vioxx

Primary outcomes

Incidence of at least one of seven predefined gastrointestinal adverse events

Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator

Important dates

Study start: 2000
Primary completion: 2001
Study completion: 2001
First posted: Mar 18, 2008
Registry last updated: Mar 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed