The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours? Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain. Participants will: Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up. Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
LTG-001 High Dose
LTG-001 Mid Dose
LTG-001 Low Dose
Placebo
Active comparator - Nav1.8 inhibitor
JBR Clinical Research
Salt Lake City, Utah, United States
SPID 0-12
Pain Intensity NRS Score change over the study.
Time frame: 12 hours
Perceptible Pain Relief
Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique.
Time frame: 12 hours
Meaningful Pain Relief
Time to Meaningful Pain Relief, assessed via 2-stopwatch technique.
Time frame: 12 hours
Time to Rescue
Time to first use of rescue medication.
Time frame: 12 hours
TOTPAR over 0 to 12 hours
Time-weighted summed pain relief as recorded on a sum of total pain relief (TOTPAR) over 0 to 12 hours (TOTPAR12) after the first dose of study drug.
Time frame: 12 hours
2 Point Reduction in Pain on 0-10 Numerical Rating Scale
Time to ≥ 2-point reduction in Numerical Rating Scale from baseline compared to placebo.
Time frame: 12 hours
Global Evaluation
Subject's global evaluation based on a 5-point scale asking, "Overall, how effective do you think the study drug is as a treatment for pain?"
Time frame: 12 hours
No Required Rescue
Subjects requiring no rescue opioid over 12 hours.
Time frame: 12 hours
Total Rescue
Total opioid rescue consumption over 12 hours.
Time frame: 12 hours
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