LTG-001 for Acute Pain After Abdominoplasty
Experimental: LTG-001 High Dose
+ Experimental: LTG-001 Low Dose
+ Active Comparator: HB/APAP
Neurologic Manifestations+2
+ Pain
+ Signs and Symptoms
Treatment Study
Summary
Study start date: July 24, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to find out if a medication called LTG-001 can effectively manage pain after undergoing an abdominoplasty, commonly known as a tummy tuck. The study focuses on people who have just had this type of surgery and aims to understand how well the drug can control pain within the first 48 hours after the operation. It also seeks to determine the most effective dose of LTG-001 and assess its safety during this period. This study is important because managing pain effectively after surgery can significantly improve recovery and comfort for patients. Participants in this study will take the medication LTG-001 twice a day after their abdominoplasty. They will stay in the clinic for about 48 hours while the medication is administered, allowing researchers to closely monitor their response to the treatment. After two weeks, participants will return for a safety check-up. During the initial 48-hour period, they will report any changes in their pain levels, helping to evaluate how well LTG-001 alleviates post-operative pain. The study will gather data on both the effectiveness and tolerability of the medication, contributing valuable information for future pain management strategies.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.360 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Subject is male or female aged 18 to 50 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
CenExel ACMR
Atlanta, United StatesHD Research LLC
Houston, United StatesEndeavor Clinical Research
San Antonio, United States