Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

Heron Therapeutics

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Device: Luer-lock applicator; Device: Vial access device; Drug: HTX-011; Drug: Saline placebo; Drug: Bupivacaine HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT03237481

HTX-011-302

Details and patient eligibility

About

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.

Enrollment: 418 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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418 participants in 3 patient groups, including a placebo group

Treatment Group 1: HTX-011

Experimental group

Description:

HTX 011 (bupivacaine/meloxicam)

Treatment:

Drug: HTX-011

Device: Vial access device

Device: Luer-lock applicator

Treatment Group 2: Bupivacaine HCI

Active Comparator group

Description:

Bupivacaine HCl

Treatment:

Drug: Bupivacaine HCl

Treatment Group 3: Saline Placebo

Placebo Comparator group

Description:

Saline placebo

Treatment:

Drug: Saline placebo

Device: Luer-lock applicator