- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367315
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
May 18, 2012 updated by: Novartis
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)
Study Overview
Study Type
Interventional
Enrollment
1684
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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Nuernberg, Germany
- Novartis
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Basel, Switzerland
- Novartis
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
- Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.
Exclusion Criteria:
- Evidence of active peptic ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
- Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
Other protocol-defined inclusion/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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Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
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Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
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Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
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Secondary Outcome Measures
Outcome Measure |
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Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
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Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
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Patient's health status using the Short Form-36 (SF-36), at week 13.
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Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
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• Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
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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.
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
September 1, 2003
Primary Completion (Actual)
February 1, 2004
Study Registration Dates
First Submitted
August 18, 2006
First Submitted That Met QC Criteria
August 18, 2006
First Posted (Estimate)
August 22, 2006
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, Knee
- 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
- CCOX189A2361
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.
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NovartisCompletedVideo Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small BowelHealthy VolunteersUnited Kingdom, Germany
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NovartisCompletedOsteoarthritisUnited States, Canada
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