The purpose of this phase 2 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
60
IV infusion of 1000 mg of VVZ-149
IV infusion of 0 mg of VVZ-149
Anaheim Clinical Trials
Anaheim, California, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Total Area Under the Curve (AUC) of Pain Intensity for 12 hours after the start of study drug infusion
Using Numeric Pain Rating Scale (NRS, 0-10 at rest)
Time frame: 0-12 hours after the start of study drug infusion
AUC of pain intensity for 24 hours after the start of study drug infusion.
Time frame: 0-24 hours after the start of study drug infusion
Total opioid consumption up to 12 hours after the start of study drug infusion.
Time frame: 0-12 hours after the start of study drug infusion
Total opioid consumption up to 24 hours after the start of study drug infusion.
Time frame: 0-24 hours after the start of study drug infusion
Percentage of cumulative subjects that used rescue medication prior to each scheduled pain intensity assessment time point.
Time frame: 0-24 hours after the start of study drug infusion
Time until the subject requested first and second rescue medications.
Time frame: 0-24 hours after the start of study drug infusion
Time to perceptible, meaningful, and confirmed perceptible pain relief.
Time frame: 0-12 hours after the start of study drug infusion
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