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This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: HTX-011 + MMA Regimen | Experimental | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen. |
|
| Cohort 2: HTX-011 + MMA Regimen + Ketorolac | Experimental | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTX-011 | Drug | HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Receiving no Opioid Rescue | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME]) | 72 hours | |
| Percentge of Subjects Receiving no Opioid Rescue | 0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Lotus Clinical Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: HTX-011 + MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen. |
| FG001 | Cohort 2: HTX-011 + MMA Regimen + Ketorolac | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: HTX-011 + MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen. |
| BG001 | Cohort 2: HTX-011 + MMA Regimen + Ketorolac |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Receiving no Opioid Rescue | Safety Population | Posted | Count of Participants | Participants | 72 hours |
|
28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: HTX-011 + MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tricia Mulford | Heron Therapeutics, Inc. | 760-622-3709 | tmulford@herontx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2018 | Jun 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2018 | Jun 11, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Luer lock applicator | Device | Applicator for instillation. |
|
| Vial access device | Device | Device for withdrawal of drug product. |
|
| Ibuprofen | Drug | Ibuprofen, 600 mg. |
|
| Acetaminophen | Drug | Acetaminophen, 1 g. |
|
| Ketorolac | Drug | Intraoperative IV ketorolac. |
|
| Percentge of Subjects Receiving no Opioid Rescue | Day 28 |
| Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable. | 72 hours |
| Pasadena |
| California |
| 91105 |
| United States |
| JBR Clinical Research | Draper | Utah | 84020 | United States |
| JBR Clinical Research | Murray | Utah | 84107 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84124 | United States |
| Withdrawal by Subject |
|
| One subject missed the Day 28 visit and one subject missed the Day 10 and Day 28 visits. |
|
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME]) | Safety Population | Posted | Mean | Standard Deviation | MME, morphine milligram equivalents | 72 hours |
|
|
|
| Secondary | Percentge of Subjects Receiving no Opioid Rescue | Safety Population | Posted | Count of Participants | Participants | 0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours |
|
|
|
| Secondary | Percentge of Subjects Receiving no Opioid Rescue | Safety Population | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable. | Safety Population | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 5 |
| 33 |
| EG001 | Cohort 2: HTX-011 + MMA Regimen + Ketorolac | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac. | 0 | 30 | 0 | 30 | 7 | 30 |
| Dizziness | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 19.1 | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 24-72 hours |
|
| 48-72 hours |
|