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COMPLETED
NCT06774625
PHASE2

This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars

Sponsor: Latigo Biotherapeutics

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-12-19

Completion Date

2025-08-08

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DRUG

LTG-001 High Dose

LTG-001 High Dose

DRUG

LTG-001 Mid Dose

LTG-001 Mid Dose

DRUG

LTG-001 Low Dose

LTG-001 Low Dose

OTHER

Placebo

Placebo

DRUG

Suzetrigine

Active comparator - Nav1.8 inhibitor

Locations (1)

JBR Clinical Research

Salt Lake City, Utah, United States