COMPLETED

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

Conditions

Acute Pain, Postoperative Acute Pain Surgical Removal of Impacted Third Molars Wisdom teeth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-12-19

Study Completion:2025-08-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06774625

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

JBR Clinical Research

Salt Lake City, Utah, 84107

United States

Collaborators and Investigators

Sponsor: Latigo Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19

Study Completion Date2025-08-08

Study Record Updates

Study Start Date2024-12-19

Study Completion Date2025-08-08

Terms related to this study

Keywords Provided by Researchers

Acute Pain
Surgical Removal of Impacted Third Molars
Wisdom teeth

Additional Relevant MeSH Terms

Acute Pain, Postoperative