Pediatric Postoperative Analgesia Herniorrhaphy Study

Heron Therapeutics

Status and phase: Withdrawn; Phase 2

Conditions: Analgesia

Treatments: Device: Luer Lock Applicator; Drug: Bupivacaine HCl; Drug: HTX-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922048

HTX-011-216

Details and patient eligibility

About

This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without 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 a planned concurrent surgical procedure (eg, bilateral herniorrhaphy).
• Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
• Has taken meloxicam within least 10 days 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 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 a body mass index (BMI) >35 kg/m2.

In addition to the preceding exclusion criteria 1 through 14, subjects to be enrolled in Cohort 1 Part B, Cohort 2 Part B, or Cohort 3 who meet any of the following criteria prior to randomization will be excluded from the study:

• Has had a prior ipsilateral inguinal 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 known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
• Has taken long-acting opioids within 3 days prior to the scheduled surgery.
• Has taken any opioids within 48 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 undergone 3 or more surgeries within 12 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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0 participants in 10 patient groups

Cohort 1 Part A: HTX-011

Experimental group

Description:

Adolescents ≥12 to \<17 years of age. A single dose of HTX-011 via instillation into the surgical site.

Treatment:

Device: Luer Lock Applicator

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Cohort 1 Part A: bupivacaine HCl

Active Comparator group

Description:

Adolescents ≥12 to \<17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site.

Treatment:

Drug: Bupivacaine HCl

Cohort 1 Part B: HTX-011

Experimental group

Description:

Adolescents ≥12 to \<17 years of age. Dose to be determined from Cohort 1 Part A.

Treatment:

Device: Luer Lock Applicator

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Cohort 1 Part B: bupivacaine HCl

Active Comparator group

Description:

Adolescents ≥12 to \<17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Treatment:

Drug: Bupivacaine HCl

Cohort 2 Part A: HTX-011

Experimental group

Description:

Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.

Treatment:

Device: Luer Lock Applicator

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Cohort 2 Part A: bupivacaine HCl

Active Comparator group

Description:

Children ≥6 to \<12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Treatment:

Drug: Bupivacaine HCl

Cohort 2 Part B: HTX-011

Experimental group

Description:

Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.

Treatment:

Device: Luer Lock Applicator

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Cohort 2 Part B: bupivacaine HCl

Active Comparator group

Description:

Children ≥6 to \<12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Treatment:

Drug: Bupivacaine HCl

Cohort 3: HTX-011

Experimental group

Description:

Children ≥3 to \<6 years of age. Dose to be determined from Cohorts 1 and 2.

Treatment:

Device: Luer Lock Applicator

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Drug: HTX-011

Cohort 3: bupivacaine HCl

Active Comparator group

Description:

Children ≥3 to \<6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Treatment:

Drug: Bupivacaine HCl