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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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
|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 July 22, 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