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 With Primary OA of Hip, Knee, Hand or Spine

NCT00145301 | Completed Phase 3

• 1 other identifier: CCOX189A2369
• Study Type: interventional
• Target: 3,036
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Osteoarthritis

Keywords

Osteoarthritis, lumiracoxib, retention on treatment, efficacy, safety

Outcome Measures

Primary Outcomes (1)

• To show that either regimen of lumiracoxib (100mg od or 100mg bid) is not inferior to celecoxib 200mg od with respect to retention rate at 1 year in pts suffering from primary OA in hip, knee, hand or spine.

Secondary Outcomes (4)

• Safety & tolerability of pts using lumiracoxib vs pts using celecoxib

• Efficacy of lumiracoxib vs celecoxib with respect to Patient's assessment of OA pain, Patient's global assessment of disease activity, and Physician's global assessment of disease activity

• To compare reasons for discontinuation from treatment with lumiracoxib vs treatment with celecoxib

• To validate the psychometric properties of the Short Arthritis assessment Scale (SAS) by analyzing pt reported outcomes collected in this study

Interventions

Lumiracoxib DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary osteoarthritis in the hip, knee, hand, or spine
• Requiring NSAID therapy

You may not qualify if:

• Secondary OA with history and/ or any evidence of the following diseases: rheumatoid arthritis, uncontrolled gout, inflammatory joint disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility), collagen gene mutations, primary fibromyalgia (secondary fibromyalgia is allowed if in the opinion of the investigator it will not interfere with the patient's OA pain assessment), and systemic lupus erythematosus
• History and/ or any evidence of the following diseases in the target joint: septic arthritis, gout, recurrent episodes of pseudogout, Paget's disease of the bone, and articular fracture. If the patient has history of these conditions, then patient should only be excluded if the target joint is affected.
• History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Nuremberg, Germany

Location

Related Publications (1)

• Fleischmann R, Tannenbaum H, Patel NP, Notter M, Sallstig P, Reginster JY. Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis. BMC Musculoskelet Disord. 2008 Mar 7;9:32. doi: 10.1186/1471-2474-9-32.

  PMID: 18328090 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

lumiracoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: September 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

DE (1)