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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:
NCT00367315
First received: August 18, 2006
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)


Condition Intervention Phase
Knee 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 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:

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
  • Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
  • Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.

Secondary Outcome Measures:
  • • Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
  • Patient's health status using the Short Form-36 (SF-36), at week 13.
  • Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Estimated Enrollment: 1684
Study Start Date: September 2003
Primary Completion Date: February 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:

  • 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367315

Locations
Germany
Novartis
Nuernberg, Germany
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00367315     History of Changes
Other Study ID Numbers: CCOX189A2361
Study First Received: August 18, 2006
Last Updated: May 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors

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

ClinicalTrials.gov processed this record on May 22, 2013