Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03907176
Recruitment Status : Enrolling by invitation
First Posted : April 8, 2019
Last Update Posted : April 10, 2019
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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, 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 31, 2019
Estimated Study Completion Date : August 31, 2019

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 receiving no opioid rescue [ Time Frame: Screening through Day 15 ]

Secondary Outcome Measures :
  1. Total postoperative opioid consumption [ Time Frame: Screening through Day 15 ]
  2. Mean total TSQM-9 score [ Time Frame: Screening through Day 15 ]
    Treatment Satisfaction Questionnaire for Medication (9-question)



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.


Layout table for eligibility information
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.
  • Has known or suspected daily use of opioids for 7 or more consecutive 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


Locations
Layout table for location information
United States, Texas
Hermann Drive Surgical Hospital
Houston, Texas, United States, 77004
Sponsors and Collaborators
Heron Therapeutics

Layout table for additonal information
Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03907176     History of Changes
Other Study ID Numbers: HTX-011-304
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Heron Therapeutics:
inguinal hernia
hernia
hernia surgery
postoperative pain
herniorrhaphy
multimodal analgesia

Additional relevant MeSH terms:
Layout table for MeSH terms
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