> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/this-is-a-study-evaluating-the-efficacy-and-safety-of-ltg-aa9026e8-67ba-4db6-8b08-edc56a09bfd6 > Record changed: 2026-11-04 # This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars NCT06774625 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) Lead sponsor Latigo Biotherapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) Start date 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Short title** This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Dates **Completion date** 2025-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **First posted** 2025-01-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Registry last updated** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Primary completion date** 2025-08-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Start date** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Size and sites **Actual participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Lead sponsor** Latigo Biotherapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Identifiers **Registry ID** NCT06774625 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **ClinicalTrials.gov ID** NCT06774625 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Outcomes ### Primary outcomes 1. SPID 0-12 Timeframe: 12 hours Pain Intensity NRS Score change over the study. ### Secondary outcomes 1. Perceptible Pain Relief Timeframe: 12 hours Time to Confirmed Perceptible Pain Relief, assessed via 2-stopwatch technique. 2. Meaningful Pain Relief Timeframe: 12 hours Time to Meaningful Pain Relief, assessed via 2-stopwatch technique. 3. Time to Rescue Timeframe: 12 hours Time to first use of rescue medication. 4. 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. 5. 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. 6. 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?" 7. No Required Rescue Timeframe: 12 hours Subjects requiring no rescue opioid over 12 hours. 8. Total Rescue Timeframe: 12 hours Total opioid rescue consumption over 12 hours. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Sites - JBR Clinical ResearchSalt Lake City, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06774625) ## Related records ### Drugs (1) - [Suzetrigine](https://trialight.com/data/asset/suzetrigine-38fea8c9-094b-4a0f-a3ac-8b8135055326.md) ### Lead sponsors (1) - [Latigo Biotherapeutics](https://trialight.com/data/company/latigo-biotherapeutics-ee3e8c36-ce23-4a77-872f-b4b5305cb236.md) ### Targets (1) - [SCN10A](https://trialight.com/data/target/scn10a-e64e3928-416a-5e6d-b348-81c46298a289.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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