None listed
Conditions
Interventions
Drug : Either VVZ-149 Injections or placebo will be added to the infusion bag to replace the withdrawn volume of saline, reverting the total volume back to 500 mL. Then, the injectable saline containi
Sponsors
Vivozon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient between the ages of 25 and 70 years old, inclusive 2. Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing 3. Patient experiencing immediate pain intensity(Numeric rating scale, NRS) of 5 or higher post-operation 4. Subject who underwent surgery specially for the clinical study 5. Subject who can submit a written consent form before participating in the test 6. Subject who can clearly communicate with the staff and the investigator 7. Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
Exclusion criteria
Exclusion criteria: 1. Surgical factors • Unplanned or emergency surgery • Reoperation (e.g. performing the same surgical procedure within 30 days of initial performance) • Subject who experiences pain associated with cancer at the surgical site prior to the surgery 2. Patient Characteristics • Premenopausal women, women of childbearing age, women currently pregnant, or capable of breastfeeding. • Subject diagnosed with chronic pain (e.g. on NRS (Numeric rating scale) scale of 1-10, sustained pain level of 4 or higher at ground state) • Subjects with psychiatric disorders that are unstable or difficult to control (e.g. untreated traumatic stress disorder, anxiety, depression) *Subjects taking (the same capacity for more than 30 days) anti-depressants or anti-anxiety medications are legible for participation • Subjects with unstable medical conditions (e.g. subjects with unstable \angina, congestive heart failure, renal failure, liver failure, AIDS) • Subjects with measure of ECG(electrocardiography) QRS >200msec or QTc > 450msec during screening 3. Drugs, alcohol, pharmacological considerations • Subject swith history of drug, alcohol, opiates, or other medical abuse/dependence. • Subjects with unidentifiable negative results in urine examination upon drug screening • Subjects who made recent use of (within 30 days of operation) or are currently still making use of steroids, opioids, antipsychotic drugs • Subjects who consumed alcohol within 24 hours prior to surgery • Subjects who made use of non-narcotic analgesic (COX (cyclooxygenase)-2 inhibitor included) or non-steroidal anti-inflammatory drug (NSAID) 24 hours within operation • Subjects who consumed herbal supplement or nutraceutical supplements (chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, valerian etc.) within 7 days before operation 4. Anesthetics and other exclusion factors • Subjects who used neurological drugs or partial anesthesia in conjunction with surgery • Subjects who used parenteral administration (all) or lidocaine (>1mg/kg) during, before, after, or even 24 hours prior to the surgery • Subjects who have hypersensitivity to opioids • Subjects who have taken other investigational drugs within 30 days prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity (Numerical Rating Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of Fentanyl consumption after administration of investigational drug;Amount of relief medication consumed of investigational drug % number of requests;Pain Intensity Difference and Sum Pain Intensity Difference;global measurement of patient satisfaction ;PK/PD correlation;Total Amount of Fentanyl consumption and rescue dose | — |
Countries
Korea, Republic of
Contacts
Public ContactNa Young Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed