Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee Surgery
Phase 4
Completed
- Conditions
- Pain
- Registration Number
- NCT00333567
- Lead Sponsor
- Novartis
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Intensity (PI) in the target knee after movement at the 2 h time-point
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis
🇩🇪Nuernberg, Germany