RECRUITING

An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-24
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07102459

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is male or female aged 18 to 50 years
  2. * Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
  3. * Has a body BMI 18.0 to 35 kg/m2
  4. * Has signed informed consent and will comply with the requirements and restrictions of the study
  5. * Meet lifestyle, medication, or other study restrictions
  6. * Subject must agree to study required use of birth control
  7. * Post-surgical (abdominoplasty) pain must meet the study threshold
  1. * Inability to take oral medications
  2. * Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
  3. * History of impaired hepatic function or heart disease.
  4. * Abnormal liver laboratories or other lab abnormality indicative of serious medical condition
  5. * Sensory abnormality that would confound post-surgery pain assessments
  6. * Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions
  7. * A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
  8. * Positive drug screen.

Contacts and Locations

Study Contact

Director of Clinical Operations
CONTACT
813-486-8342
msonnemann@latigobio.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Latigo Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-24
Study Completion Date2026-01

Study Record Updates

Study Start Date2025-07-24
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Acute Pain
  • Abdominoplasty

Additional Relevant MeSH Terms

  • Acute Pain
  • Postoperative Pain Control