None listed
Conditions
Interventions
Drug : The VVZ-149 treatment group will receive a dosing regimen of a continuous 10-hour IV infusion of VVZ-149
VVZ-149 (1,000 mg) mixed into saline.
The placebo group will be administered with a placebo in the same way as the VVZ-149 treatment group for 10 hours.
Sponsors
Vivozon Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women must be at least 18 years of age. 2. Female subjects who are not pregnant or breastfeeding. 3. Subjects must be undergoing a planned first laparoscopic colectomy. 4. Subjects classified in American Society Anesthesiologist (ASA) risk class of I or II. 5. Subjects who report the pain intensity = 5 on the NRS (NRS: Numeric Rating Scale, 0~10) measured after surgery. 6. Subjects must have the ability to understand study procedures and communicate clearly with the investigator and staff. 7. Subjects must have the ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: Surgical Factors 1. Subjects undergoing emergency or unplanned surgery. 2. Subjects who had a previous laparoscopic colectomy procedure, or who had any laparoscopic resection procedure. 3. Subjects with pre-existing conditions causing preoperative pain at the site of surgery Subject Characteristics 4. Women who are pregnant or breastfeeding. 5. Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS = 5 at baseline) 6. Unstable or poorly controlled psychiatric conditions (e.g., post-traumatic stress disorder, anxiety, or depression). Antidepressant and antianxiety medication are allowed as long as the subject has been on a stable dose for at least 60 days prior to screening. Intraoperative antianxiety drugs are allowed. 7. Unstable, acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, or acquired immunodeficiency syndrome). 8. Clinically significant ECG findings as determined by the investigator at the screening visit: Prolonged QRS duration (> 200 msec), QTcF > 450 msec (male) or > 470 msec (female). 9. Body weight 1 mg/kg) intra- or peri-operatively, or within 24 hours of surgery. 20. Subjects with known allergies or hypersensitivity to opioids. 21. Subjects who received another investigational drug within 30 days of the scheduled surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (SPID 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Total number of PCA requests for 12 hours post-dose;2) Total amount of PCA and rescue medications consumption for 12 hours post-dose;3) Proportion of subjects with = 40% decrease in pain area at 6 hours post-dose;4) Time-weighted SPID from baseline over 24 hours post-dose (SPID 24) | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Hyon Back
Seoul National University Hospital
Outcome results
None listed