The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain? Participants will: Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
343
High Dose Active
Lower Dose Active
Active Comparator
Placebo
Arizona Research Center
Phoenix, Arizona, United States
CenExel ACMR
Atlanta, Georgia, United States
HD Research LLC
Houston, Texas, United States
Endeavor Clinical Research
San Antonio, Texas, United States
JBR Clinical Research (CenExel)
Salt Lake City, Utah, United States
SPIDr0-48
Time-weighted SPIDr0-48 after the first dose of study drug.
Time frame: 48 hours
Total Opioid Rescue
Total opioid rescue medication consumption from 0 48 hours, using MMEs
Time frame: 48 hours
No Opioid requirement
Proportion of participants requiring no opioid rescue medication over 48 hours
Time frame: 48 hours
Nausea and Vomiting
Incidence of nausea or vomiting
Time frame: 48 hours
2-Point NPRS Reduction
Time to ≥2-point reduction in NPRS from baseline
Time frame: 48 hours
1-Point NPRS Reduction
Time to ≥1-point reduction in NPRS from baseline
Time frame: 48 Hours
PID at 60 minutes
Time-specific PID at 60 minutes
Time frame: 1 hour
SPID r0-24
Time-weighted SPIDr0-24 after the first dose of study drug
Time frame: 24 hours
Patient Global Assessment
Proportion of participants with favorable PGA of study drug at end of treatment
Time frame: 48 Hours
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