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

Launched by LATIGO BIOTHERAPEUTICS · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called LTG-001 to see if it can help relieve pain after surgery to remove impacted wisdom teeth, also known as third molars. The researchers want to find out if LTG-001 is effective in reducing pain over a 12-hour period after surgery and if it is safe for patients to use. To do this, participants will receive either LTG-001 or a placebo (a substance without the active drug) after their surgery and will be monitored for 12 hours at the clinic to track their pain levels.

To participate in this study, you need to be between 18 and 50 years old and scheduled for the removal of two or more wisdom teeth. Additionally, you should weigh at least 45 kg and have a body mass index (BMI) within a certain range. Participants will need to stay at the clinic for 12 hours after taking the medication and return for a follow-up appointment a week later. It’s important to know that certain health conditions and medications might make you ineligible for the study, so it's best to discuss this with your doctor if you're interested.

Gender

ALL

Eligibility criteria

• 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.