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Pediatric Postoperative Analgesia Herniorrhaphy Study

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ClinicalTrials.gov Identifier: NCT03922048
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Brief Summary:
This is a Phase 2, double-blind study in pediatric subjects undergoing inguinal herniorrhaphy.

Condition or disease Intervention/treatment Phase
Analgesia Drug: HTX-011 Device: Luer lock applicator Drug: Bupivacaine HCl Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of HTX-011 for Postoperative Analgesia in Adolescents and Children (≥3 to <17 Years of Age) Undergoing Unilateral Open Inguinal Herniorrhaphy
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 Part A: HTX-011
Adolescents ≥12 to <17 years of age. A single dose of HTX-011 via instillation into the surgical site.
Drug: HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.

Device: Luer lock applicator
Applicator for instillation.

Active Comparator: Cohort 1 Part A: bupivacaine HCl
Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site.
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) 0.5 to 1.0 mL/kg (total dose not to exceed 75 mg).

Experimental: Cohort 1 Part B: HTX-011
Adolescents ≥12 to <17 years of age. Dose to be determined from Cohort 1 Part A.
Drug: HTX-011
Dose to be determined from Cohort 1 Part A.

Active Comparator: Cohort 1 Part B: bupivacaine HCl
Adolescents ≥12 to <17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) 0.5 to 1.0 mL/kg (total dose not to exceed 75 mg).

Experimental: Cohort 2 Part A: HTX-011
Children ≥6 to <12 years of age. Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohort 1.

Active Comparator: Cohort 2 Part A: bupivacaine HCl
Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) 0.5 to 1.0 mL/kg (total dose not to exceed 75 mg).

Experimental: Cohort 2 Part B: HTX-011
Children ≥6 to <12 years of age. Dose to be determined from Cohort 1.
Drug: HTX-011
Dose to be determined from Cohort 1.

Active Comparator: Cohort 2 Part B: bupivacaine HCl
Children ≥6 to <12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) 0.5 to 1.0 mL/kg (total dose not to exceed 75 mg).

Experimental: Cohort 3: HTX-011
Children ≥3 to <6 years of age. Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011
Dose to be determined from Cohorts 1 and 2.

Active Comparator: Cohort 3: bupivacaine HCl
Children ≥3 to <6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site
Drug: Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) 0.5 to 1.0 mL/kg (total dose not to exceed 75 mg).




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf) [ Time Frame: 72 hours ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: 72 hours ]
  3. Time to maximum plasma concentration (Tmax) [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Adolescents ≥12 to <17 years of age (Cohort 1): area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) [ Time Frame: 72 hours ]
  2. Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores [ Time Frame: 72 hours ]
  3. Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores [ Time Frame: 72 hours ]
  4. Total postoperative opioid consumption (in IV morphine milligram equivalents) [ Time Frame: 72 hours ]
  5. Proportion of subjects who are opioid-free [ Time Frame: 72 hours ]
  6. AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R) [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 16 Years   (Child)
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:

  • 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 had a prior ipsilateral inguinal herniorrhaphy.
  • 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 underlying history of chronic opioid use or opioid abuse.
  • 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) >35 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 ClinicalTrials.gov identifier (NCT number): NCT03922048


Contacts
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Contact: Erol Onel (858) 251-4420 HTX011-ct@herontx.com

Locations
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United States, Texas
Plano Surgical Hospital Recruiting
Plano, Texas, United States, 92101
Sponsors and Collaborators
Heron Therapeutics

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03922048     History of Changes
Other Study ID Numbers: HTX-011-216
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
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
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
postoperative pain
herniorrhaphy
pediatric
local anesthetic
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents