The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
307
IV infusion of 1000 mg of VVZ-149
IV infusion of 0 mg of VVZ-149
Arizona Research Center
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours post-emergence
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
Time frame: 0-12 hours post-emergence
Proportion of patients who report mild pain (NRS 0-3) at each time point during 24 hours post-emergence
Time frame: 0-24 hours post-emergence
Total number of requests for rescue medication for 24 hours post-emergence
Time frame: 0-24 hours post-emergence
Total amount of rescue medication consumption for 12 hours post-emergence
Time frame: 0-12 hours post-emergence
Total amount of intra-operative fentanyl use
Time frame: During surgery
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JBR Clinical Research
Salt Lake City, Utah, United States