Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00333567
First received: June 1, 2006
Last updated: December 12, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333567

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

No publications provided

ClinicalTrials.gov Identifier: NCT00333567     History of Changes
Other Study ID Numbers: CCOX189A2427
Study First Received: June 1, 2006
Last Updated: December 12, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
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 April 17, 2014