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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907176
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Brief Summary:
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.

Condition or disease Intervention/treatment Phase
Analgesia Drug: HTX-011 Device: Luer lock applicator Drug: Ibuprofen Drug: Acetaminophen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In Part 1, subjects who meet the Screening eligibility criteria (Section 4.1) will be randomized to one of the 2 parallel cohorts. In Part 2, prior to surgery, the Investigator will select for the subject one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

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

Device: Luer lock applicator
Applicator for instillation

Drug: Ibuprofen
600 mg

Drug: Acetaminophen
1 g

Experimental: Cohort 2
HTX-011; Ibuprofen and Acetaminophen (regimen 2)
Drug: HTX-011
300 mg

Device: Luer lock applicator
Applicator for instillation

Drug: Ibuprofen
600 mg

Drug: Acetaminophen
1 g




Primary Outcome Measures :
  1. Proportion of subjects who do not receive an opioid prescription at discharge through the day 15 visit [ Time Frame: Discharge through Day 15 ]

Secondary Outcome Measures :
  1. Proportion of subjects who do not receive an opioid prescription at discharge [ Time Frame: At discharge ]
  2. Proportion of subjects who do not receive a postdischarge opioid prescription, through the Day 15 visit. [ Time Frame: Postdischarge through Day 15 ]
  3. Pain intensity scores at the time of discharge [ Time Frame: At discharge ]
  4. Number of oxycodone pills taken between discharge and the Day 15 visit [ Time Frame: Postdischarge through Day 15 ]
  5. Mean TSQM-9 scores [ Time Frame: Day 15 plus or minus 2 days ]


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 and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural).
  • Has an American Society of Anesthesiologists (ASA) 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:

  • 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.
  • Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months.
  • Has taken any opioids within 24 hours prior to the scheduled surgery.
  • 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 uncontrolled anxiety, psychiatric, or neurological disorder.
  • Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.

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): NCT03907176


Contacts
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Contact: Chris Storgard, MD (858) 251-4452 cstorgard@herontx.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Heron Therapeutics
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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03907176    
Other Study ID Numbers: HTX-011-304
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
hernia surgery
postoperative pain
herniorrhaphy
multimodal analgesia
Additional relevant MeSH terms:
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Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action