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Efficacy and Safety of Lumiracoxib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00267215
First received: December 16, 2005
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.


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 One-week Multicenter, Multiple-dose, Randomized, Double-blind, Double-dummy, Parallel-group Comparison of the Analgesic Efficacy and Safety of Lumiracoxib (COX189), Celecoxib, and Placebo in the Treatment of Osteoarthritis of the Knee

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid

Secondary Outcome Measures:
  • Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib

Estimated Enrollment: 330
Study Start Date: November 2000
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion criteria:

  • Osteoarthritis of the knee
  • Pain intensity at baseline of at least 50mm on a 100mm visual analog scale

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267215

Locations
Germany
Novartis
Nuernberg, Germany
Sponsors and Collaborators
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: NCT00267215     History of Changes
Other Study ID Numbers: CCOX189A2301
Study First Received: December 16, 2005
Last Updated: May 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Lumiracoxib
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lumiracoxib
Diclofenac
Cyclooxygenase 2 Inhibitors
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