The purpose of this phase 3 study is to evaluate the efficacy and safety of VVZ-149 Injections for the treatment of postoperative pain following laparoscopic colectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
285
IV infusion of 1000 mg of VVZ-149
IV infusion of 0 mg of VVZ-149
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Seoul National University Hospital
Time-weighted Sum of Pain Intensity Differences for 12 Hours Post-dose (SPID 12)
Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). Time-weighted Sum of Pain Intensity Difference (PID) for 12 hours post-dose (SPID 12) was estimated using the linear trapezoidal rule (L x Hour) with the PI scores assigned from Time 0 to Time 12 hours post-dose using the following formula. The theoretical SPID 12 ranges from 0 to 120. A higher value of SPID indicates greater pain relief. SPID 12 = S \[T(i)-T(i-1)\] × \[PID(i)+PID(i-1)\]/2, when PID(i) =Predose PI-PI at Time i
Time frame: 0-12 hours post-dose
Total Number of Patient-controlled Analgesia (PCA) Requests for 12 Hours Post-dose
Total number of patient-controlled analgesia (PCA) requests from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.
Time frame: 0-12 hours post-dose
Total Amount of PCA and Rescue Medication Consumption for 12 Hours Post-dose
Total amount of PCA and rescue medication consumption from Time 0 to Time 12 hours was compared between the VVZ-149 Injections group and the placebo group.
Time frame: 0-12 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seoul, South Korea