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This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing abdominoplasty (Cohort 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 Cohort 2 | Experimental | HTX-011 + MMA regimen |
|
| Treatment Group 2 Cohort 2 | Active Comparator | Bupivacaine HCl + MMA regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTX-011 | Drug | 400 mg |
| |
| Bupivacaine Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). | Through Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of bupivacaine and meloxicam | Through 144 hours | |
| Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam | Through 144 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Surgical Hospital | Bellaire | Texas | 77401 | United States | ||
| Endeavor Clinical Trials, LLC |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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In each cohort, subjects will be randomized in a 2:1 ratio to HTX-011 or bupivacaine HCl, respectively. All subjects will receive a scheduled postoperative non opioid multimodal analgesic (MMA) regimen.
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| Drug |
125 mg |
|
| Ibuprofen | Drug | 400 mg |
|
| Acetaminophen | Drug | 1 g |
|
| Luer lock applicator | Device | Applicator for instillation |
|
| Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam |
| Through 144 hours |
| Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam | Through 144 hours |
| Apparent terminal half-life (t½) of bupivacaine and meloxicam | Through 144 hours |
| San Antonio |
| Texas |
| 78229 |
| United States |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D000588 |
| Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D000083 | Acetanilides |