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Completed

NCT Number: NCT00154219

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

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Various Sites, Multiple Cities, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lumiracoxib (drug)

Drug

Primary outcomes

  1. WOMAC 3.1 LK questionnaire after 13 weeks of treatment

  2. Patient's global assessment of disease activity (VAS) after 13 weeks of treatment

Secondary outcomes

  1. Overall OA pain intensity (VAS)by visit

  2. Physician's global assessment of disease activity (VAS) by visit

  3. Response to treatment according to OARSI criteria by visit

  4. Actual OA pain intensity at 12 hours post-dose by visit

  5. Number of rescue tablets taken during the study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 12, 2005
Registry last updated
May 21, 2012

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.

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