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
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: 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
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
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 02, 2014