Clinical trial NCT06774625: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Pain, Postoperative
Keywords: Acute Pain
Surgical Removal of Impacted Third Molars
Wisdom teeth
Lead sponsor: Latigo Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: SPID 0-12
timeFrame: 12 hours
Secondary outcomes:
measure: Perceptible Pain Relief
timeFrame: 12 hours
measure: Meaningful Pain Relief
timeFrame: 12 hours
measure: Time to Rescue
timeFrame: 12 hours
measure: TOTPAR over 0 to 12 hours
timeFrame: 12 hours
measure: 2 Point Reduction in Pain on 0-10 Numerical Rating Scale
timeFrame: 12 hours
measure: Global Evaluation
timeFrame: 12 hours
measure: No Required Rescue
timeFrame: 12 hours
measure: Total Rescue
timeFrame: 12 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
References: