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Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333567
First Posted: June 5, 2006
Last Update Posted: December 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery

Condition Intervention Phase
Pain Drug: Lumiracoxib Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy of a Single Dose of Lumiracoxib 400 mg Given Pre-Emptively Versus Post-Operatively, in Reducing Pain Associated With Ambulatory Arthroscopic Knee Surgery

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pain Intensity (PI) in the target knee after movement at the 2 h time-point

Secondary Outcome Measures:
  • PI at 1, 2, 3, 4 and 24 h time-points while at rest
  • PI at 1, 3, 4 and 24 h time-points after movement
  • Time to first rescue medication intake
  • Patient's global evaluation of response to study medication
  • Safety and tolerability profile

Estimated Enrollment: 110
Study Start Date: August 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who need scheduled minor ambulatory arthroscopic knee surgery.

Exclusion Criteria:

  • Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333567


Locations
Germany
Novartis
Nuernberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharma AG Novartis
  More Information

ClinicalTrials.gov Identifier: NCT00333567     History of Changes
Other Study ID Numbers: CCOX189A2427
First Submitted: June 1, 2006
First Posted: June 5, 2006
Last Update Posted: December 13, 2007
Last Verified: December 2007

Keywords provided by Novartis:
arthroscopic knee surgery
cyclooxygenase-2 inhibitors
lumiracoxib
COX189
Ambulatory arthroscopic knee surgery

Additional relevant MeSH terms:
Lumiracoxib
Diclofenac
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents