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 bunionectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
IV infusion of 1000 mg of VVZ-149
IV infusion of 0 mg of VVZ-149
Arizona Clinical Trial Site
Phoenix, Arizona, United States
RECRUITINGCalifornia Clinical Trial Site
Anaheim, California, United States
RECRUITINGTexas Clinical Trial Site
San Antonio, Texas, United States
RECRUITINGTime-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
Using Numeric Pain Rating Scale (NRS, 0-10)
Time frame: 0-12 hours post-dose
Time to onset of perceptible pain relief using the double stopwatch method
Time frame: 0-12 hours post-dose
Total number of rescue medication request between 0-12 hours post-dose
Time frame: 0-12 hours post-dose
Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
Time frame: 0-6 hours post-dose
Proportion of patients who take prescription opioid after discharge
Time frame: 2 weeks after discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.