Acute Pain, Postoperative
Conditions
Keywords
Acute Pain, Surgical Removal of Impacted Third Molars, Wisdom teeth
Brief summary
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
Interventions
DRUGLTG-001 High Dose
LTG-001 High Dose
DRUGLTG-001 Mid Dose
LTG-001 Mid Dose
DRUGLTG-001 Low Dose
LTG-001 Low Dose
OTHERPlacebo
Placebo
DRUGSuzetrigine
Active comparator - Nav1.8 inhibitor
Sponsors
Latigo Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subject is male or female aged 18 to 50 years, inclusive, at the time of signing the informed consent * Has a body weight ≥ 45 kg and a BMI ≤ 35 kg/m2. * Subject requires extraction of 2 or more third molars, two of which must be mandibular molars that must be fully or partially bony, or combination of one fully and one partially bony impaction. * Subject must agree to study required use of birth control. * Post-surgical pain must meet protocol requirements.
Exclusion criteria
* Inability to take oral medications * Prior dental surgery within 60 days or other surgical history that could confound surgery or post-operative procedures. * History of impaired hepatic function or heart disease. * Abnormal liver laboratories or other lab abnormality indicative of serious medical condition. * Sensory abnormality that would confound post-surgery pain assessments. * Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions. * A subject with sleep apnea and/or on a home continuous positive airway pressure machine. * Positive drug screen. * Participant is under legal custodianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPID 0-12 | 12 hours | Pain Intensity NRS Score change over the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meaningful Pain Relief | 12 hours | Time to Meaningful Pain Relief, assessed via 2-stopwatch technique. |
| Time to Rescue | 12 hours | Time to first use of rescue medication. |
| TOTPAR over 0 to 12 hours | 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. |
| Perceptible Pain Relief | 12 hours | Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique. |
| Global Evaluation | 12 hours | 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? |
| No Required Rescue | 12 hours | Subjects requiring no rescue opioid over 12 hours. |
| Total Rescue | 12 hours | Total opioid rescue consumption over 12 hours. |
| 2 Point Reduction in Pain on 0-10 Numerical Rating Scale | 12 hours | Time to ≥ 2-point reduction in Numerical Rating Scale from baseline compared to placebo. |
Countries
United States
Outcome results
None listed