Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

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Novartis

Status and phase

Completed
Phase 3

Conditions

Osteoarthritis, Hip

Treatments

Drug: Lumiracoxib (drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00154219
CCOX189A2367

Details and patient eligibility

About

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 osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of primary hip osteoarthritis
  • Qualifying pain intensity in the hip joint
  • Requiring NSAID therapy

Exclusion criteria

  • Rheumatoid arthritis or other inflammatory joint disease
  • Disease or disorder that may interfere with pain assessment of the hip
  • Open knee/hip surgery within the last year
  • Past history of heart attack, stroke or angina (chest pain)
  • Liver disorder
  • History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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