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Phase 3 Herniorrhaphy Study for Postoperative Analgesia (EPOCH 2)

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ClinicalTrials.gov Identifier: NCT03237481
Recruitment Status : Completed
First Posted : August 2, 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 unilateral open inguinal herniorrhaphy.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 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 Open Inguinal Herniorrhaphy
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : January 16, 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), 300 mg/9 mg by instillation

Device: Luer-lock applicator
Applicator for instillation

Device: Vial access device
Device for withdrawal of drug product
Active Comparator: Treatment Group 2: Bupivacaine HCI
Bupivacaine HCl
 Drug: Bupivacaine HCl
Bupivacaine HCl without epinephrine, 75 mg by injection
Placebo Comparator: Treatment Group 3: Saline Placebo
Saline placebo
 Drug: Saline placebo
Saline placebo by instillation

Device: Luer-lock applicator
Applicator for instillation


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), sitting up from a resting position.


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), sitting up from a resting position.

  2. Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) for HTX 011 Compared With Saline Placebo. [ Time Frame: 72 hours ]
  3. Percetange 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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Information from the National Library of Medicine

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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 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.
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): NCT03237481


Locations
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Sponsors and Collaborators
Heron Therapeutics
  Study Documents (Full-Text)

Documents provided by Heron Therapeutics:
Study Protocol  [PDF] July 30, 2017
Statistical Analysis Plan  [PDF] October 24, 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: NCT03237481    
Other Study ID Numbers: HTX-011-302
First Posted: August 2, 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
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Heron Therapeutics:
inguinal hernia
hernia
hernia surgery
postoperative pain
herniorrhaphy
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