Acute Pain, Postoperative Pain Control
Conditions
Keywords
Acute Pain, Abdominoplasty
Brief 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.
Interventions
DRUGExperimental: LTG-001 High Dose
High Dose Active
DRUGExperimental: LTG-001 Low Dose
Lower Dose Active
DRUGActive Comparator: HB/APAP
Active Comparator
DRUGPlacebo Comparator
Placebo
Sponsors
Latigo Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPIDr0-48 | 48 hours | Time-weighted SPIDr0-48 after the first dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Rescue | 48 hours | Total opioid rescue medication consumption from 0 48 hours, using MMEs |
| No Opioid requirement | 48 hours | Proportion of participants requiring no opioid rescue medication over 48 hours |
| 2-Point NPRS Reduction | 48 hours | Time to ≥2-point reduction in NPRS from baseline |
| 1-Point NPRS Reduction | 48 Hours | Time to ≥1-point reduction in NPRS from baseline |
| Nausea and Vomiting | 48 hours | Incidence of nausea or vomiting |
| PID at 60 minutes | 1 hour | Time-specific PID at 60 minutes |
| SPID r0-24 | 24 hours | Time-weighted SPIDr0-24 after the first dose of study drug |
| Patient Global Assessment | 48 Hours | Proportion of participants with favorable PGA of study drug at end of treatment |
Countries
United States
Outcome results
None listed