Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib
Phase 4
Completed
- Conditions
- Pain
- Registration Number
- NCT00348491
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 364
Inclusion Criteria
- Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular
- Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery
Exclusion Criteria
- Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8)
- Secondary Outcome Measures
Name Time Method Time-specific PID based on VAS at time-points up to 24 hours after dosing Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables:
Trial Locations
- Locations (1)
Dental Research Clinic
🇺🇸Austin, Texas, United States