An Efficacy and Safety Study of LTG-001 Following Abdominoplasty (NCT07102459) | Clinical Trial Compass
CompletedPhase 2
An Efficacy and Safety Study of LTG-001 Following Abdominoplasty
United States343 participantsStarted 2025-07-24
Plain-language summary
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001.
The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain?
Participants will:
Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
Who can participate
Age range
18 Years – 65 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 65 years
* Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
* Has a body BMI 18.0 to 35 kg/m2
* Has signed informed consent and will comply with the requirements and restrictions of the study
* Meet lifestyle, medication, or other study restrictions
* Subject must agree to study required use of birth control
* Post-surgical (abdominoplasty) pain must meet the study threshold
Exclusion Criteria:
* Inability to take oral medications
* Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
* 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.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.