Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
NCT ID: NCT03295721
Last Updated: 2025-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
412 participants
INTERVENTIONAL
2017-10-24
2018-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment Group 1: HTX-011
HTX 011 (bupivacaine/meloxicam)
HTX-011
HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation
Luer-lock applicator
Applicator for instillation
Vial access device
Device for withdrawal of drug product
Treatment Group 2: Saline Placebo
Saline placebo
Saline Placebo
Saline placebo by instillation
Luer-lock applicator
Applicator for instillation
Treatment Group 3: Bupivacaine HCI
Bupivacaine HCl
Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg by injection
Interventions
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HTX-011
HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation
Saline Placebo
Saline placebo by instillation
Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg by injection
Luer-lock applicator
Applicator for instillation
Vial access device
Device for withdrawal of drug product
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 bunionectomy or collateral procedures on the surgical foot).
* Has other 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 at least 10 days prior to the scheduled surgery.
* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has initiated treatment with 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. Subjects taking medical marijuana are not allowed to participate in the 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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Locations
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Springhill Medical Center
Mobile, Alabama, United States
Orthopaedic Specialists of North America, PLLC
Mesa, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Trovare Clinical Research, Inc.
Bakersfield, California, United States
Alliance Research Centers
Laguna Hills, California, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, United States
Optimal Research , LLC
Austin, Texas, United States
Hermann Drive Surgical Hospital
Houston, Texas, United States
Westside Surgical Hospital
Houston, Texas, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
Plano Surgical Hospital
Plano, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
EPIC Medical Research, LLC
Murray, Utah, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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References
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Yip T, Hu J, Hawn PS, Yamamoto A, Oderda G. HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly. Pain Manag. 2022 Jan;12(1):45-57. doi: 10.2217/pmt-2021-0043. Epub 2021 Jul 21.
Viscusi E, Gimbel JS, Pollack RA, Hu J, Lee GC. HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study. Reg Anesth Pain Med. 2019 May 21:rapm-2019-100531. doi: 10.1136/rapm-2019-100531. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HTX-011-301
Identifier Type: -
Identifier Source: org_study_id
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