RECRUITING

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

Description

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.

Conditions

Acute PainPostoperative Pain Control
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Related Conditions:

Acute PainPostoperative Pain Control

Study Overview

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Study Details

Study overview

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.

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

Condition
Acute Pain
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

JBR Clinical Research, Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Latigo Biotherapeutics,

Study Record Dates

2026-01