This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars
- 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
- Short title
- This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG 001 for Acute Pain After Surgical Removal of Impacted Third Molars
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-08-08
- First posted
- 2025-01-14
- Registry last updated
- 2026-05-22
- Primary completion date
- 2025-08-08
- Start date
- 2024-12-19
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Latigo Biotherapeutics
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06774625
- ClinicalTrials.gov ID
- NCT06774625
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
SPID 0-12
Timeframe: 12 hours
Pain Intensity NRS Score change over the study.
Perceptible Pain Relief
Timeframe: 12 hours
Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique.
Meaningful Pain Relief
Timeframe: 12 hours
Time to Meaningful Pain Relief, assessed via 2-stopwatch technique.
Time to Rescue
Timeframe: 12 hours
Time to first use of rescue medication.
TOTPAR over 0 to 12 hours
Timeframe: 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.
2 Point Reduction in Pain on 0-10 Numerical Rating Scale
Timeframe: 12 hours
Time to ≥ 2-point reduction in Numerical Rating Scale from baseline compared to placebo.
Global Evaluation
Timeframe: 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
Timeframe: 12 hours
Subjects requiring no rescue opioid over 12 hours.
Total Rescue
Timeframe: 12 hours
Total opioid rescue consumption over 12 hours.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Healthy volunteers
- No
- 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.
- 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.
- JBR Clinical ResearchSalt Lake City, United States