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This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTX-011 + Alternating MMA Regimen | Experimental | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake. |
|
| HTX-011 + Concurrent MMA Regimen | Experimental | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTX-011 | Drug | 300 mg bupivacaine/9 mg meloxicam |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit | Through Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge | Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average). | At discharge |
| Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Horizon Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | HTX-011 + Alternating MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake. |
| FG001 | HTX-011 + Concurrent MMA Regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 12, 2019 | Jun 8, 2023 |
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In Part 1, subjects will be randomized to one of the 2 parallel postoperative MMA regimens. In Part 2, the Investigator will select one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.
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| Luer lock applicator | Device | Applicator for instillation |
|
| Ibuprofen | Drug | 600 mg |
|
| Acetaminophen | Drug | 1 g |
|
| Postdischarge through Day 15 |
| Pain Intensity Scores at the Time of Discharge | Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position. | At discharge |
| Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit | Postdischarge through Day 15 |
| Mean TSQM-9 Scores | The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction. | Day 15 plus or minus 2 days |
| La Mesa |
| California |
| 91942 |
| United States |
| Sharp Grossmont Hospital | La Mesa | California | 91942 | United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| Parkview Community Hospital | Riverside | California | 92503 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Medical Research of Westchester, Inc | Miami | Florida | 33144 | United States |
| Professional Health Care of Pinellas | St. Petersburg | Florida | 33713 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Baylor University Medical Center | Dallas | Missouri | 75246 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Rutgers - New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Montefiore Hutchinson Campus | The Bronx | New York | 10461 | United States |
| M3 Emerging Medical Research, LLC | Durham | North Carolina | 27704 | United States |
| Cleveland Clinic Fairview | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center - University Hospital | Columbus | Ohio | 43210 | United States |
| Midwest Clinical Research Center, LLC | Dayton | Ohio | 45417 | United States |
| Summit Medical Group Oregon-Bend Memorial Clinic | Bend | Oregon | 97701 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Hermann Drive Surgical Hospital | Houston | Texas | 77004 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Plano Surgical Hospital | Plano | Texas | 75093 | United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | United States |
| JBR Clinical Research | Draper | Utah | 84020 | United States |
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HTX-011 + Alternating MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake. |
| BG001 | HTX-011 + Concurrent MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake. |
| BG002 | Total | Total of all reporting groups |
| 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 | 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 |
|
| 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 | Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit | Posted | Count of Participants | Participants | Through Day 15 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge | Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average). | Posted | Count of Participants | Participants | At discharge |
|
| |||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit. | Posted | Count of Participants | Participants | Postdischarge through Day 15 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Pain Intensity Scores at the Time of Discharge | Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position. | The study was enrolled in 2 parts, NRS-A was not collected in the second part of the study. | Posted | Mean | Standard Deviation | score on a scale | At discharge |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit | Overall Number of Participants Analyzed equals only the subjects taking opioids between discharge and the Day 15 visit. | Posted | Mean | Full Range | Number of oxycodone 5 mg pills | Postdischarge through Day 15 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean TSQM-9 Scores | The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction. | TSQM-9 Scores on Regimen 1 missing for 3 subjects for Effectiveness Domain and Global Satisfaction Domain and 7 subject for Convenience Domain. | Posted | Mean | Standard Deviation | score on a scale | Day 15 plus or minus 2 days |
|
|
29 Days.
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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 | HTX-011 + Alternating MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake. | 0 | 102 | 1 | 102 | 7 | 102 |
| EG001 | HTX-011 + Concurrent MMA Regimen | HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake. | 0 | 107 | 0 | 107 | 14 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peptic Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tricia Mulford | Heron Therapeutics, Inc. | 760-622-3709 | tmulford@herontx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2019 | Jun 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000723006 | bupivacaine-meloxicam drug combination |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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