Clinical Trial: Efficacy and Safety Study of Lumiracoxib in Patients with Primary Hip Osteoarthritis

This study is currently recruiting patients.
Verified by Novartis September 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00154219

Purpose

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]).
Condition Intervention Phase
Osteoarthritis, Hip
 Drug: Lumiracoxib (drug)
Phase III

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official 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

Further Study Details: 

Study start: November 2004

Eligibility

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both
Criteria

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00154219

Novartis Pharmaceuticals      862-778-8300 
Novartis Pharmaceuticals      41 61 324 1111 

New Jersey
      For US Site Information, contact Novartis Pharmaceuticals, East Hanover,  New Jersey,  07936,  United States; Recruiting
 862-778-8300 

Canada
      Various Sites, Multiple Cities,  Canada; Recruiting
 862-778-8300 

Germany
      Various Sites, Multiple Cities,  Germany; Not yet recruiting
 41 61 324 1111 

Italy
      Various Sites, Multiple Cities,  Italy; Not yet recruiting
 41 61 324 1111 

United Kingdom
      Various Sites, Multiple Cities,  United Kingdom; Not yet recruiting
 41 61 324 1111 

More Information

Study ID Numbers:  CCOX189A2367
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00154219
Health Authority: United States: Food and Drug Administration; Canada: Therapeutic Products Directorate
ClinicalTrials.gov processed this record on 2005-09-13

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