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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03922048
Other study ID # HTX-011-216
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date July 2023
Est. completion date December 2025

Study information

Verified date June 2023
Source Heron Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 16 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Bupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
HTX-011
Dose to be determined from Cohort 1.
HTX-011
Dose to be determined from Cohorts 1 and 2.
HTX-011
Dose to be determined from Cohort 1 Part A.
Device:
Luer Lock Applicator
Applicator for instillation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Heron Therapeutics

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf) 72 hours
Primary Maximum concentration (Cmax) 72 hours
Primary Time of occurrence of maximum concentration (Tmax) 72 hours
Secondary 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) 72 hours
Secondary Children =6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores 72 hours
Secondary Children =3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores 72 hours
Secondary Total postoperative opioid consumption (in IV morphine milligram equivalents) 72 hours
Secondary Proportion of subjects who are opioid-free 72 hours
Secondary AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R) 72 hours
Secondary Proportion of subjects who do not receive an opioid prescription at discharge. 72 hours
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