This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Remov… (NCT06774625) | Clinical Trial Compass
CompletedPhase 2
This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars
United States250 participantsStarted 2024-12-19
Plain-language 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
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for LTG-001 that has already completed, what results or safety data have come out of it, and how might that information affect whether this drug could ever be an option for me?
2The trial measured something called SPID 0-12, which tracks pain relief over 12 hours after wisdom tooth removal — does that short window of pain measurement tell us enough about how well LTG-001 controls pain during the full recovery period, or are there gaps in what we'd know?
3Because this was a Phase 2 study, the main goal was still establishing efficacy and safety in a relatively small group — does that mean there isn't yet enough evidence to know how LTG-001 compares to standard pain medications like ibuprofen or prescription options I might already be offered after oral surgery?
4Given that this trial specifically studied people having impacted third molars removed, would the findings even apply to my particular situation, or is my pain management need different enough that standard treatments would be a better starting point?
5Since the trial is completed but I'm not sure if results have been published yet, is there a way for you to access the outcome data so we can have an informed conversation about whether LTG-001 might eventually become a real option for post-surgical pain?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.