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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTG-001 High Dose | Experimental | High Dose LTG-001 |
|
| LTG-001 Low Dose | Experimental |
| |
| HB/APAP | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: LTG-001 High Dose | Drug | High Dose Active |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SPIDr0-48 | Time-weighted SPIDr0-48 after the first dose of study drug. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Rescue | Total opioid rescue medication consumption from 0 48 hours, using MMEs | 48 hours |
| No Opioid requirement | Proportion of participants requiring no opioid rescue medication over 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| CenExel ACMR |
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| Experimental: LTG-001 Low Dose |
| Drug |
Lower Dose Active |
|
| Active Comparator: HB/APAP | Drug | Active Comparator |
|
| Placebo Comparator | Drug | Placebo |
|
| 48 hours |
| 2-Point NPRS Reduction | Time to ≥2-point reduction in NPRS from baseline | 48 hours |
| 1-Point NPRS Reduction | Time to ≥1-point reduction in NPRS from baseline | 48 Hours |
| Nausea and Vomiting | Incidence of nausea or vomiting | 48 hours |
| PID at 60 minutes | Time-specific PID at 60 minutes | 1 hour |
| SPID r0-24 | Time-weighted SPIDr0-24 after the first dose of study drug | 24 hours |
| Patient Global Assessment | Proportion of participants with favorable PGA of study drug at end of treatment | 48 Hours |
| Atlanta |
| Georgia |
| 30331 |
| United States |
| HD Research LLC | Houston | Texas | 77043 | United States |
| Endeavor Clinical Research | San Antonio | Texas | 78240 | United States |
| JBR Clinical Research (CenExel) | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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