52 Week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability & Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid & Celecoxib 200 mg od in Pts Wi
Summary
This trial will compare the retention on treatment (based on the rate of patients staying on treatment for 1 year) of patients suffering from primary osteoarthritis using two different doses of lumiracoxib (100 mg od or 100 mg bid) or using celecoxib (200 mg od)
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Osteoarthritis
Intervention
Lumiracoxib
Location
Novartis
Nuernberg
Germany
Status
Completed
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00145301
- Information obtained from ClinicalTrials.gov on June 14, 2012
Medical and Biotech [MESH] Definitions
Ketoprofen
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.
Viscosupplements
Viscoelastic solutions that are injected into JOINTS in order to alleviate symptoms of joint-related disorders such as OSTEOARTHRITIS.
Hallux Rigidus
A condition caused by degenerative arthritis (see OSTEOARTHRITIS) of the METATARSOPHALANGEAL JOINT of the great toe and characterized by pain and limited dorsiflexion, but relatively unrestricted plantar flexion.
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.
Piroxicam
A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.
Clinical Trials
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarth...
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
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
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 i...
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who partic...
Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
PubMed Articles
PURPOSE: To re-evaluate the cardiovascular risk of lumiracoxib compared with other non-steroidal anti-inflammatory drugs (NSAIDs) or placebo in patients with osteoarthritis. METHODS: We conducted a me...
A 13-week, multicenter, randomized, double-blind study of lumiracoxib in hip osteoarthritis.
The aim of this 13-week, multicenter, randomized, double-blind, double-dummy, placebo- and positive-internal (celecoxib)-controlled, parallel-group study was to demonstrate the efficacy, safety, and t...
A genome-wide study identifies HLA alleles associated with lumiracoxib-related liver injury.
Lumiracoxib is a selective cyclooxygenase-2 inhibitor developed for the symptomatic treatment of osteoarthritis and acute pain. Concerns over hepatotoxicity have contributed to the withdrawal or non-a...
Severe acute liver injury associated with lumiracoxib.
Backgound: Significant elevations in liver transaminases were noted in some patients during pre-marketing clinical trials with lumiracoxib, a selective COX-2 inhibitor. It was withdrawn from the Austr...
Crohn's disease (CD) is associated with gut barrier dysfunction. Besides the baseline barrier defect, a subgroup of patients also expresses an intestinal barrier hyperresponsiveness to nonsteroidal an...
