Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
A Phase 3, Randomized, Double Blind, Saline Placebo and Active Controlled, Multicenter Study of HTX 011 Via Local Administration for Postoperative Analgesia and Decreased Opioid Use Following Unilateral Simple Bunionectomy
1 other identifier
interventional
412
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 postoperative-pain
Started Oct 2017
Shorter than P25 for phase_3 postoperative-pain
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedStudy Start
First participant enrolled
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2018
CompletedResults Posted
Study results publicly available
October 27, 2021
CompletedMarch 2, 2026
February 1, 2026
3 months
September 25, 2017
June 11, 2021
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Saline Placebo.
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing).
72 hours
Secondary Outcomes (4)
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 72 Hours Postsurgery (AUC0-72), Compared With Bupivacaine HCl.
72 hours
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.
72 hours
Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.
72 hours
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.
72 hours
Study Arms (3)
Treatment Group 1: HTX-011
EXPERIMENTALHTX 011 (bupivacaine/meloxicam)
Treatment Group 2: Saline Placebo
PLACEBO COMPARATORSaline placebo
Treatment Group 3: Bupivacaine HCI
ACTIVE COMPARATORBupivacaine HCl
Interventions
Bupivacaine HCl without epinephrine, 50 mg by injection
Applicator for instillation
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Springhill Medical Center
Mobile, Alabama, 36608, United States
Orthopaedic Specialists of North America, PLLC
Mesa, Arizona, 85206, United States
Arizona Research Center
Phoenix, Arizona, 85059, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Trovare Clinical Research, Inc.
Bakersfield, California, 93301, United States
Alliance Research Centers
Laguna Hills, California, 92653, United States
Chesapeake Research Group, LLC
Pasadena, Maryland, 21122, United States
Optimal Research , LLC
Austin, Texas, 78705, United States
Hermann Drive Surgical Hospital
Houston, Texas, 77004, United States
Westside Surgical Hospital
Houston, Texas, 77027, United States
Futuro Clinical Trials, LLC
McAllen, Texas, 78501, United States
Plano Surgical Hospital
Plano, Texas, 75093, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
EPIC Medical Research, LLC
Murray, Utah, 84123, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (2)
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.
PMID: 34284613DERIVEDViscusi 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.
PMID: 31113830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tricia Mulford
- Organization
- Heron Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2017
First Posted
September 28, 2017
Study Start
October 24, 2017
Primary Completion
January 8, 2018
Study Completion
March 13, 2018
Last Updated
March 2, 2026
Results First Posted
October 27, 2021
Record last verified: 2026-02