- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00154219
Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
May 18, 2012 updated by: Novartis
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
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]).
Study Overview
Study Type
Interventional
Enrollment
1200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Cities, Canada
- Various sites
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Multiple Cities, Germany
- Various sites
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Multiple Cities, Italy
- Various sites
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Multiple Cities, United Kingdom
- Various sites
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New Jersey
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East Hanover, New Jersey, United States, 07936
- For US Site Information, contact Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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WOMAC 3.1 LK questionnaire after 13 weeks of treatment
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Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Overall OA pain intensity (VAS)by visit
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Physician's global assessment of disease activity (VAS) by visit
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Response to treatment according to OARSI criteria by visit
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Actual OA pain intensity at 12 hours post-dose by visit
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Number of rescue tablets taken during the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
May 21, 2012
Last Update Submitted That Met QC Criteria
May 18, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Hip
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Lumiracoxib
Other Study ID Numbers
- CCOX189A2367
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Hip
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Istituto Ortopedico RizzoliRecruiting
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University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
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CHU de ReimsCompleted
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Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
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Daiichi Sankyo, Inc.TerminatedSymptomatic Hip OsteoarthritisFrance
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University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
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Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
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University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
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Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
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Lawson Health Research InstituteCompletedHip Osteoarthritis | Hip ArthroplastyCanada
Clinical Trials on Lumiracoxib (drug)
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Novartis PharmaceuticalsCompletedOsteoarthritis | Controlled HypertensionGermany, United States
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NovartisCompletedOsteoarthritisCzech Republic, Germany, Finland, Hungary, Australia, Austria, Turkey, Poland, Israel, Spain, South Africa, Slovakia, Sweden, Netherlands, New Zealand
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JW PharmaceuticalCompleted
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GlaxoSmithKlineCompleted
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CelltrionCompletedHealth, SubjectiveKorea, Republic of
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Novus Therapeutics, IncCompletedHealthy Adult VolunteersUnited States
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JW PharmaceuticalCompleted
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University of ZurichUniversity Hospital, Zürich; Center of Competence Multimorbidity, ZurichCompletedDiabetes Complications | Gastrointestinal Hemorrhage | MultimorbiditySwitzerland
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JW PharmaceuticalCompletedHealthyKorea, Republic of