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

A 52-week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability and Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid and Celecoxib 200 mg od in Patients With Primary Osteoarthritis of Hip, Knee, Hand or Spine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00145301

Enrollment

3036

Registered

2005-09-05

Start date

2004-09-30

Completion date

Unknown

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, lumiracoxib, retention on treatment, efficacy, safety

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)

Interventions

DRUGLumiracoxib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* 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. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026