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Phase 2 Herniorrhaphy Study for Opioid Elimination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03695367
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
Heron Therapeutics

Brief Summary:
This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.

Condition or disease Intervention/treatment Phase
Analgesia Drug: HTX-011 Device: Luer lock applicator Device: Vial access device Drug: Ibuprofen Drug: Acetaminophen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : December 15, 2018

Arm Intervention/treatment
Experimental: Cohort 1
HTX-011; Ibuprofen and Acetaminophen (alternating)
Drug: HTX-011
HTX-011, 300 mg

Device: Luer lock applicator
Applicator for instillation

Device: Vial access device
Device for withdrawal of drug product

Drug: Ibuprofen
Ibuprofen, 600 mg

Drug: Acetaminophen
Acetaminophen, 1 g

Primary Outcome Measures :
  1. Proportion of subjects receiving no opioid rescue [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Total postoperative opioid consumption (in IV morphine milligram equivalents [IV MME]) [ Time Frame: 72 hours ]
  2. Proportion of subjects receiving no opioid rescue [ Time Frame: 72 hours ]
  3. Proportion of subjects receiving no opioid rescue [ Time Frame: Day 28 ]
  4. Proportion of subjects in severe pain with Numeric Rating Scale (NRS) of pain intensity scores >7 on a scale of 0-10 at any point. NRS for pain where 0 equals no pain and 10 equals worst pain imaginable. [ Time Frame: 72 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 except as a child (less than 6 years of age).
  • Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
  • Has a 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 least 10 days prior to the scheduled surgery.
  • Has taken long-acting opioids within 3 days prior to the scheduled surgery.
  • Has taken any opioids within 24 hours prior to the scheduled surgery.
  • Has been administered bupivacaine within 5 days prior to the scheduled surgery.
  • Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
  • Has initiated treatment with study 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 at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study.
  • Previously participated in an HTX-011 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.

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 identifier (NCT number): NCT03695367

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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
United States, Utah
JBR Clinical Research
Draper, Utah, United States, 84020
JBR Clinical Research
Murray, Utah, United States, 84107
JBR Clinical Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Heron Therapeutics
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Study Chair: Neil Singla, MD Lotus Clinical Research, LLC

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Responsible Party: Heron Therapeutics Identifier: NCT03695367    
Other Study ID Numbers: HTX-011-215
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Heron Therapeutics:
inguinal hernia
hernia surgery
postoperative pain
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action