Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery
This study has been completed.
Information provided by:
First received: June 1, 2006
Last updated: December 12, 2007
Last verified: December 2007
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
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:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients who need scheduled minor ambulatory arthroscopic knee surgery.
- 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333567
|Nuernberg, Germany |
||Novartis Pharma AG
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 1, 2006
||December 12, 2007
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Novartis:
arthroscopic knee surgery
Ambulatory arthroscopic knee surgery
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2014
Cyclooxygenase 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents