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This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Bupivacaine HCl | Experimental | Bupivacaine HCl without epinephrine, via injection into the surgical site. |
|
| Cohort 2: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam) via application into the surgical site. |
|
| Cohort 3: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam) via application into the surgical site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine HCI without epinephrine | Drug | 100 mg administered via injection into the surgical site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events | From the time the subject signs the ICF through the Day 29 Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Baseline through 120 hours | |
| Time of occurrence of maximum concentration (Tmax) | Baseline through 120 hours | |
| Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast) |
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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 | ||
| Lotus Clinical Research, LLC |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Optional Part B will be randomized, blinded, active-controlled.
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| HTX-011 | Drug | HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site. |
|
| Luer Lock Applicator | Device | Applicator for instillation. |
|
| Baseline through 120 hours |
| Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) | Baseline through 120 hours |
| Apparent terminal half-life (t½) | Baseline through 120 hours |
| Pasadena |
| California |
| 91105 |
| United States |
| Kansas Spine and Specialty Hospital | Wichita | Kansas | 67226 | United States |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
| Overlook Medical Center | Summit | New Jersey | 07901 | United States |
| M3 Emerging Medical Research, LLC | Durham | North Carolina | 27704 | United States |
| The Ohio State University Wexner Medical Center - University Hospital | Columbus | Ohio | 43210 | United States |
| Austin Neurosurgeons | Austin | Texas | 78746 | United States |
| First Surgical Hospital | Bellaire | Texas | 77401 | United States |
| Houston Heights Hospital | Houston | Texas | 77008 | United States |
| South Texas Spine & Surgical Center | San Antonio | Texas | 78258 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |