Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Postoperative Pain

In brief

This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.

Key facts

Study ID: NCT03295721
Run by: Heron Therapeutics
People needed: 412
Starts: 2017-10-24
Expected to finish: 2018-03-13
Last updated by the study team: 2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Is scheduled to undergo a primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
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.

You may not qualify if…

Has had a contralateral foot bunionectomy in the past 3 months.
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.

Where it is running

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

Full record on ClinicalTrials.gov

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