Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00476034
First received: May 18, 2007
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.


Condition Intervention Phase
Osteoarthritis
Drug: lumiracoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 39-week, Double-blind, Active-controlled Extension to CCOX189A2361, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
  • Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
  • Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
  • Patient's functional status using the WOMAC total score at 26 weeks

Secondary Outcome Measures:
  • To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
  • To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
  • Overall OA pain intensity on a 0-100 mm VAS by visit
  • Patient's global assessment of disease activity by visit
  • Physician's global assessment of disease activity by visit
  • Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
  • Usage of rescue medication
  • Response to treatment according to OARSI criteria by visit

Enrollment: 1312
Study Start Date: December 2003
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.

Exclusion Criteria:

  • Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
  • Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476034

Locations
Australia
Novartis Investigative Site
Malvern, Australia
Austria
Novartis Investigative Site
Vienna, Austria
Czech Republic
Novartis Investigative Site
Prague, Czech Republic
Finland
Novartis Investigative Site
Turku, Finland
Germany
Novartis Investigative Site
Dresden, Germany
Hungary
Novartis Investigative Site
Budapest, Hungary
Israel
Novartis Investigative Site
Haifa, Israel
Netherlands
Novartis Investigative Site
Lisse, Netherlands
New Zealand
Novartis Investigative Site
Rotorua, New Zealand
Poland
Novartis Investigative Site
Poznan, Poland
Slovakia
Novartis Investigative Site
Bratislava, Slovakia
South Africa
Novartis Investigative Site
Johannesburg, South Africa
Spain
Novartis Investigative Site
Sevilla, Spain
Sweden
Novartis Investigative Site
Uppsala, Sweden
Turkey
Novartis Investigative Site
Izmir, Turkey
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00476034     History of Changes
Other Study ID Numbers: CCOX189A2361E1
Study First Received: May 18, 2007
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Agency for Safety in Health Care
Australia: Department of Health and Ageing Therapeutic Goods Administration
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Turkey: Ministry of Health

Keywords provided by Novartis:
Osteoarthritis
lumiracoxib
celecoxib
Cox-2
knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lumiracoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014