A Phase 2 interventional study of HTX-011 and Bupivacaine HCl in Analgesia, sponsored by Heron Therapeutics. Withdrawn. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Heron Therapeutics · Phase 2, Interventional, and Treatment
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
Browse Hernia, Inguinal studies →Heron Therapeutics is the lead sponsor of 26 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 12 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adolescents ≥12 to \<17 years of age. A single dose of HTX-011 via instillation into the surgical site.
Drug: HTX-011 · Device: Luer Lock Applicator
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
Adolescents ≥12 to \<17 years of age. Dose to be determined from Cohort 1 Part A.
Drug: HTX-011 · Device: Luer Lock Applicator
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
Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.
Drug: HTX-011 · Device: Luer Lock Applicator
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
Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.
Drug: HTX-011 · Device: Luer Lock Applicator
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
Children ≥3 to \<6 years of age. Dose to be determined from Cohorts 1 and 2.
Drug: HTX-011 · Device: Luer Lock Applicator
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
Drug pages: Bupivacaine · Meloxicam
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
Drug pages: Bupivacaine · Meloxicam
Dose to be determined from Cohort 1.
Drug pages: Bupivacaine · Meloxicam
Dose to be determined from Cohorts 1 and 2.
Drug pages: Bupivacaine · Meloxicam
Dose to be determined from Cohort 1 Part A.
Applicator for instillation.
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Time frame: 72 hours
Maximum concentration (Cmax)
Time frame: 72 hours
Time of occurrence of maximum concentration (Tmax)
Time frame: 72 hours
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
Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores
Time frame: 72 hours
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
Total postoperative opioid consumption (in IV morphine milligram equivalents)
Time frame: 72 hours
Proportion of subjects who are opioid-free
Time frame: 72 hours
AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)
Time frame: 72 hours
Proportion of subjects who do not receive an opioid prescription at discharge.
Time frame: 72 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Nov 2025, 28 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bupivacaine · Meloxicam