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Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295721
Recruitment Status : Completed
First Posted : September 28, 2017
Results First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: HTX-011 Drug: Saline Placebo Drug: Bupivacaine HCl Device: Luer-lock applicator Device: Vial access device Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : March 13, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group 1: HTX-011
HTX 011 (bupivacaine/meloxicam)
 Drug: HTX-011
HTX 011 (bupivacaine/meloxicam), 60 mg/1.8 mg by instillation

Device: Luer-lock applicator
Applicator for instillation

Device: Vial access device
Device for withdrawal of drug product
Placebo Comparator: Treatment Group 2: Saline Placebo
Saline placebo
 Drug: Saline Placebo
Saline placebo by instillation

Device: Luer-lock applicator
Applicator for instillation
Active Comparator: Treatment Group 3: Bupivacaine HCI
Bupivacaine HCl
 Drug: Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg by injection


Outcome Measures
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Primary Outcome Measures :
  1. Mean Area Under the Curve (AUC) of the Numeric Rating Scale of Pain Intensity Scores With Activity (NRS-A; Windowed Worst Observation Carried Forward) for HTX-011 Compared With Saline Placebo. [ Time Frame: 72 hours ]
    Pain intensity scores are assessed 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), seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).


Secondary Outcome Measures :
  1. Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl. [ Time Frame: 72 hours ]
    Pain intensity scores are assessed 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) seated with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).

  2. Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. [ Time Frame: 72 hours ]
  3. Percentage of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl. [ Time Frame: 72 hours ]
  4. Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl. [ Time Frame: 72 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295721


Locations
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United States, Alabama
Springhill Medical Center
Mobile, Alabama, United States, 36608
United States, Arizona
Orthopaedic Specialists of North America, PLLC
Mesa, Arizona, United States, 85206
Arizona Research Center
Phoenix, Arizona, United States, 85059
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Trovare Clinical Research, Inc.
Bakersfield, California, United States, 93301
Alliance Research Centers
Laguna Hills, California, United States, 92653
United States, Maryland
Chesapeake Research Group, LLC
Pasadena, Maryland, United States, 21122
United States, Texas
Optimal Research , LLC
Austin, Texas, United States, 78705
Hermann Drive Surgical Hospital
Houston, Texas, United States, 77004
Westside Surgical Hospital
Houston, Texas, United States, 77027
Futuro Clinical Trials, LLC
McAllen, Texas, United States, 78501
Plano Surgical Hospital
Plano, Texas, United States, 75093
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
United States, Utah
EPIC Medical Research, LLC
Murray, Utah, United States, 84123
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Heron Therapeutics
  Study Documents (Full-Text)

Documents provided by Heron Therapeutics:
Study Protocol  [PDF] September 24, 2017
Statistical Analysis Plan  [PDF] October 10, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03295721    
Other Study ID Numbers: HTX-011-301
First Posted: September 28, 2017    Key Record Dates
Results First Posted: October 27, 2021
Last Update Posted: October 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Heron Therapeutics:
bunion
bunionectomy
bunion surgery
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents