Back to results

Pediatric Postoperative Analgesia Herniorrhaphy Study

Primary Purpose

Analgesia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

HTX-011

Bupivacaine HCl

HTX-011

Luer Lock Applicator

About this trial

This is an interventional treatment trial for Analgesia focused on measuring inguinal hernia, postoperative pain, herniorrhaphy, pediatric, local anesthetic

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cohort 1 Part A: HTX-011

Cohort 1 Part A: bupivacaine HCl

Cohort 1 Part B: HTX-011

Cohort 1 Part B: bupivacaine HCl

Cohort 2 Part A: HTX-011

Cohort 2 Part A: bupivacaine HCl

Cohort 2 Part B: HTX-011

Cohort 2 Part B: bupivacaine HCl

Cohort 3: HTX-011

Cohort 3: bupivacaine HCl

Arm Description

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)

Maximum concentration (Cmax)

Time of occurrence of maximum concentration (Tmax)

Secondary Outcome Measures

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)

Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores

Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores

Total postoperative opioid consumption (in IV morphine milligram equivalents)

Proportion of subjects who are opioid-free

AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)

Proportion of subjects who do not receive an opioid prescription at discharge.

Full Information

NCT ID

NCT03922048

First Posted

April 17, 2019

Last Updated

June 1, 2023

Sponsor

Heron Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03922048

Brief Title

Pediatric Postoperative Analgesia Herniorrhaphy Study

Official Title

A Phase 2, 2-Part, Open-Label, Dose-Finding and 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn due to lack of enrollment.

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Heron Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesia

Keywords

inguinal hernia, postoperative pain, herniorrhaphy, pediatric, local anesthetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 Part A: HTX-011

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 1 Part A: bupivacaine HCl

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cohort 1 Part B: HTX-011

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 1 Part B: bupivacaine HCl

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cohort 2 Part A: HTX-011

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2 Part A: bupivacaine HCl

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cohort 2 Part B: HTX-011

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2 Part B: bupivacaine HCl

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cohort 3: HTX-011

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3: bupivacaine HCl

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HTX-011

Intervention Description

Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.

Intervention Type

Drug

Intervention Name(s)

Bupivacaine HCl

Intervention Description

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Intervention Type

Drug

Intervention Name(s)

HTX-011

Intervention Description

Dose to be determined from Cohort 1.

Intervention Type

Drug

Intervention Name(s)

HTX-011

Intervention Description

Dose to be determined from Cohorts 1 and 2.

Intervention Type

Drug

Intervention Name(s)

HTX-011

Intervention Description

Dose to be determined from Cohort 1 Part A.

Intervention Type

Device

Intervention Name(s)

Luer Lock Applicator

Intervention Description

Applicator for instillation.

Primary Outcome Measure Information:

Title

Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)

Time Frame

72 hours

Title

Maximum concentration (Cmax)

Time Frame

72 hours

Title

Time of occurrence of maximum concentration (Tmax)

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

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

Title

Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores

Time Frame

72 hours

Title

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

Title

Total postoperative opioid consumption (in IV morphine milligram equivalents)

Time Frame

72 hours

Title

Proportion of subjects who are opioid-free

Time Frame

72 hours

Title

AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)

Time Frame

72 hours

Title

Proportion of subjects who do not receive an opioid prescription at discharge.

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Pediatric Postoperative Analgesia Herniorrhaphy Study

We'll reach out to this number within 24 hrs