Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2018-10-01
2018-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Cohort 1: HTX-011 + MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
HTX-011
HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
Luer lock applicator
Applicator for instillation.
Vial access device
Device for withdrawal of drug product.
Ibuprofen
Ibuprofen, 600 mg.
Acetaminophen
Acetaminophen, 1 g.
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.
HTX-011
HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
Luer lock applicator
Applicator for instillation.
Vial access device
Device for withdrawal of drug product.
Ibuprofen
Ibuprofen, 600 mg.
Acetaminophen
Acetaminophen, 1 g.
Ketorolac
Intraoperative IV ketorolac.
Interventions
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HTX-011
HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.
Luer lock applicator
Applicator for instillation.
Vial access device
Device for withdrawal of drug product.
Ibuprofen
Ibuprofen, 600 mg.
Acetaminophen
Acetaminophen, 1 g.
Ketorolac
Intraoperative IV ketorolac.
Eligibility Criteria
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Inclusion Criteria
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Exclusion Criteria
* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
* Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
* Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
* Has taken long-acting opioids within 3 days prior to the scheduled surgery.
* Has taken any opioids within 24 hours prior to the scheduled surgery.
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
* Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
* Has uncontrolled anxiety, psychiatric, or neurological disorder.
* Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.
* Previously participated in an HTX-011 study.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
* Has undergone 3 or more surgeries within 12 months.
* Has a body mass index (BMI) \>39 kg/m2.
18 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Singla, MD
Role: STUDY_CHAIR
Lotus Clinical Research, LLC
Locations
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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
JBR Clinical Research
Draper, Utah, United States
JBR Clinical Research
Murray, Utah, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HTX-011-215
Identifier Type: -
Identifier Source: org_study_id