Bunionectomy Study for Postoperative Analgesia (EPOCH 1)

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: HTX-011; Drug: Saline Placebo; Drug: Bupivacaine HCl; Device: Luer-lock applicator; Device: Vial access device

• Registration Number: NCT03295721
• Lead Sponsor: Heron Therapeutics

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-28
• Study Start: 2017-10-24
• Primary Completion: 2018-01-08
• Study Completion: 2018-03-13
• Disposition First Submitted: 2018-06-08
• Results First Submitted: 2021-06-11
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-29
• Disposition First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Results First Posted: 2021-10-27
• Disposition First Posted: 2021-10-27
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 2: Saline Placebo	Luer-lock applicator	Saline placebo
Treatment Group 1: HTX-011	HTX-011	HTX 011 (bupivacaine/meloxicam)
Treatment Group 1: HTX-011	Luer-lock applicator	HTX 011 (bupivacaine/meloxicam)
Treatment Group 1: HTX-011	Vial access device	HTX 011 (bupivacaine/meloxicam)
Treatment Group 2: Saline Placebo	Saline Placebo	Saline placebo
Treatment Group 3: Bupivacaine HCI	Bupivacaine HCl	Bupivacaine HCl

Primary Outcome Measures

Name	Time	Method
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.	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

Name	Time	Method
Mean AUC of the NRS-A Pain Intensity Scores (Windowed Worst Observation Carried Forward) for HTX 011 Compared With Bupivacaine HCl.	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).
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

Trial Locations

Locations (15)

Springhill Medical Center; 🇺🇸 Mobile, Alabama, United States

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

Trovare Clinical Research, Inc.; 🇺🇸 Bakersfield, California, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Alliance Research Centers; 🇺🇸 Laguna Hills, California, United States

Hermann Drive Surgical Hospital; 🇺🇸 Houston, Texas, United States

Chesapeake Research Group, LLC; 🇺🇸 Pasadena, Maryland, United States

Optimal Research , LLC; 🇺🇸 Austin, 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

Orthopaedic Specialists of North America, PLLC; 🇺🇸 Mesa, Arizona, United States