Evaluating LTG-001 for pain relief after wisdom teeth removal
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
This study is testing if a new pain relief medication called LTG-001 can help adults feel better after having their wisdom teeth removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Latigo Biotherapeutics Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06774625 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of LTG-001 in treating acute pain following the surgical removal of impacted third molars in adults. Participants will receive LTG-001 or a placebo after their surgery and will be monitored for pain relief over a 12-hour period. The study includes a comparison of different doses of LTG-001 against a placebo and a comparator drug to determine its effectiveness and tolerability. Participants will also return for a follow-up safety check one week post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 who require the extraction of multiple impacted third molars.
Not a fit: Patients with a history of certain medical conditions or those unable to take oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide effective pain relief for patients recovering from wisdom teeth extraction.
How similar studies have performed: Other studies have explored pain management after dental surgeries, but the specific use of LTG-001 is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salt Lake City, Utah
- JBR Clinical Research — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Director of Clinical Operations
- Email: msonnemann@latigobio.com
- Phone: 813-486-8342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.