Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

Overview

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 unilateral open inguinal herniorrhaphy.

Full Title of Study: “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 Open Inguinal Herniorrhaphy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 22, 2017

Interventions

  • Drug: HTX-011
    • HTX 011, 300 mg
  • Drug: Bupivacaine HCl
    • Bupivacaine HCl without epinephrine, 75 mg
  • Drug: Saline placebo
    • Saline placebo
  • Device: Luer-lock applicator
    • Applicator for instillation
  • Device: Vial access device
    • Device for withdrawal of drug product

Arms, Groups and Cohorts

  • Experimental: Treatment Group 1
    • HTX 011
  • Active Comparator: Treatment Group 2
    • Bupivacaine HCl
  • Placebo Comparator: Treatment Group 3
    • Saline placebo

Clinical Trial Outcome Measures

Primary Measures

  • Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) for HTX 011 compared with saline placebo.
    • Time Frame: 72 hours

Secondary Measures

  • Mean AUC of the NRS-A pain intensity scores for HTX 011 compared with bupivacaine HCl.
    • Time Frame: 72 hours
  • Mean total postoperative opioid consumption (in morphine equivalents) for HTX 011 compared with saline placebo.
    • Time Frame: 72 hours
  • Proportion of subjects who are opioid-free for HTX-011 compared with bupivacaine HCl.
    • Time Frame: 72 hours
  • Mean total postoperative opioid consumption (in morphine equivalents) for HTX 011 compared with bupivacaine HCl.
    • Time Frame: 72 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general 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:

  • Had any prior inguinal hernia repair. – Has a planned concurrent surgical procedure. – 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 NSAIDs within 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. – Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C. – Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments. – 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) 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heron Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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