Clinical trial NCT03237481: Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)
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 Open Inguinal Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: inguinal hernia
hernia
hernia surgery
postoperative pain
herniorrhaphy
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-08-02
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 unilateral open inguinal herniorrhaphy.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 72 hours
Secondary outcomes:
measure: 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.
timeFrame: 72 hours
measure: Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo.
timeFrame: 72 hours
measure: Percetange of Subjects Who Are Opioid-free for HTX-011 Compared With Bupivacaine HCl.
timeFrame: 72 hours
measure: Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Bupivacaine HCl.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Florence
country: United States
facility: Eliza Coffee Memorial Hospital
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Trials, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Bakersfield
country: United States
facility: Trovare Clinical Research, Inc.
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Riverside
country: United States
facility: HD Research Corp
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Longwood
country: United States
facility: Cornerstone Research Institute, LLC
state: Florida
city: Maitland
country: United States
facility: Park Place Surgery Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Las Vegas
country: United States
facility: eStudySite
state: Nevada
city: Dayton
country: United States
facility: Midwest Clinical Research
state: Ohio
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Westside Surgical Hospital
state: Texas
city: Plano
country: United States
facility: Plano Surgical Hospital
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, P.A.
state: Texas
city: Murray
country: United States
facility: EPIC Medical Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
Study officials:
References:
citation: Minkowitz H, Soto R, Fanikos J, Hammer GB, Mehta N, Hu J, Redan J. Opioid-Free Recovery After Hernia Repair with HTX-011 as the Foundation of a Non-Opioid, Multimodal Analgesia Regimen in a Real-World Setting: A Randomized, Open-Label Study. Pain Ther. 2021 Dec;10(2):1295-1308. doi: 10.1007/s40122-021-00289-2. Epub 2021 Jul 27.
citation: 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.