An Efficacy and Safety Study of LTG-001 Following Abdominoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-24

Study Completion Date

2026-01-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Pain Postoperative Pain Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LTG-001 High Dose

High Dose LTG-001

Group Type EXPERIMENTAL

Experimental: LTG-001 High Dose

Intervention Type DRUG

High Dose Active

LTG-001 Low Dose

Group Type EXPERIMENTAL

Experimental: LTG-001 Low Dose

Intervention Type DRUG

Lower Dose Active

HB/APAP

Group Type ACTIVE_COMPARATOR

Active Comparator: HB/APAP

Intervention Type DRUG

Active Comparator

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Placebo

Interventions

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Experimental: LTG-001 High Dose

High Dose Active

Intervention Type DRUG

Experimental: LTG-001 Low Dose

Lower Dose Active

Intervention Type DRUG

Active Comparator: HB/APAP

Active Comparator

Intervention Type DRUG

Placebo Comparator

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No