Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension
- Registration Number
- NCT01484652
- Lead Sponsor
- Mallinckrodt
- Brief Summary
The primary objective of this study is to show the effectiveness of repeated doses of COV795 versus placebo, using the summed pain intensity difference over the first 48 hours in subjects with acute moderate to severe pain following bunionectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 329
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COV795 COV795 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method SPID48 (Summed Pain Intensity Difference) 48 hours Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Trovare Clinical Research, Inc.
🇺🇸Bakersfield, California, United States
Lotus Clinical Research, LLC
🇺🇸Pasedena, California, United States
Chesapeake Research Group, LLC
🇺🇸Pasadena, Maryland, United States
Endeavor Clinical Trials, PA
🇺🇸San Antonio, Texas, United States
Jean Brown Research, Inc.
🇺🇸Salt Lake City, Utah, United States