BunionsPhase 1/2NCT04398329

Dose-Escalation Study of HTX-034 Following Bunionectomy

A Phase 1/2 study testing HTX-034 low dose, HTX-034 high dose and Luer lock applicator in people with Bunions and Postoperative Pain, run by Heron Therapeutics at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bunions, Postoperative Pain
What is being tested?: HTX-034 low dose, HTX-034 high dose and Luer lock applicator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 4 sitesUnited States
Study dates: 8 May 2020to 15 Jul 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
Has an American Society of Anesthesiologists (ASA) 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.

Who cannot join

Had contralateral foot bunionectomy in the past 3 months.
Has a planned concurrent surgical procedure.
Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
Has received or is taking a contraindicated or prohibited medications.
Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.

Show all 20Show fewer

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.
Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
Has a history of coronary artery bypass graft surgery within 12 months.
Has a history of known or suspected coagulopathy.
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 undergone 3 or more surgeries within 12 months.
Has a known history of glucose-6-phosphate dehydrogenase deficiency.
Has any of the following laboratory abnormalities during Screening (1 retest permitted):
Severe liver function impairment.
Severe kidney function impairment.
Platelet count <100,000/μL, hemoglobin <12 g/dL, or hematocrit <35%.
Has a body mass index (BMI) >39 kg/m2.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

First Surgical Hospital
Bellaire, Texas, 77401
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84017
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation

Conditions: Bunions, Postoperative Pain
Being tested: HTX-034 low dose, HTX-034 high dose, Luer lock applicator, Bupivacaine HCl
Keywords: Analgesia, Bunionectomy
Medical subject headings: Bunion, Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HTX-034 low doseDrug
HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg
HTX-034 high doseDrug
HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
Luer lock applicatorDevice
Applicator for instillation
Bupivacaine HClDrug
Bupivacaine HCl 50 mg

Study groups in NCT04398329
Study group	Role	What they receive
Phase 1b: HTX-034 Low Dose	Experimental	Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses). Receives: Drug: HTX-034 low dose; Device: Luer lock applicator
Phase 1b: HTX-034 High Dose	Experimental	Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses). Receives: Drug: HTX-034 high dose; Device: Luer lock applicator
Phase 2: HTX-034 Low Dose	Experimental	Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses). Receives: Drug: HTX-034 low dose; Device: Luer lock applicator
Phase 2: HTX-034 High Dose	Experimental	Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses). Receives: Drug: HTX-034 high dose; Device: Luer lock applicator
Phase 1b/2: Bupivacaine HCl	Active comparator	Bupivacaine HCl (without epinephrine) 0.5%: 50 mg Receives: Drug: Bupivacaine HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of TEAEs in Phases 1b/2
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Measured: 42 days
AUC0-72 of Pain Scores
Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Measured: through 72 hours

Secondary outcomes (9)

Cmax for HTX-034
Maximum plasma concentration
Measured: 29 days
Tmax for HTX-034
Time of maximum plasma concentration
Measured: 29 days
AUClast for HTX-034
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration
Measured: 29 days
AUCinf for HTX-034
Area under the concentration-time curve from Time 0 extrapolated to infinity (Phase 1b only)
Measured: 22 days
t½ of HTX-034
Apparent terminal half-life of HTX-034 (Phase 1b only)
Measured: 22 days
Mean AUC of Pain Scores With Activity
Mean AUC of the Numeric Rating Scale (NRS) scores with activity (windowed worst observation carried forward). Pain intensity scores were assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Measured: 7 days
Opioid Consumption
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents). The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Measured: 7 days
Proportion of Subjects Who Are Opioid-free
Proportion of subjects who took no postoperative opioids through Day 15. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Measured: After surgery (Day 1) through the Day 15 visit
Number of Participants With SAEs
Number and proportion of subjects with serious adverse events. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202015 Jul 2021

First posted21 May 2020
Study start8 May 2020
Primary completion15 Jul 2021
Study completion15 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BunionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04398329
Sponsor's protocol ID: HTX-034-101
Status last verified: Jun 2026
First submitted: 18 May 2020
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Postsurgical Analgesia After Unilateral Bunionectomy
Bunionectomy, Bunion
Not yet recruitingPhase 3
Phase 3 Bunionectomy Study
Postoperative Pain, Bunion
Active, not recruiting
LSTR in Chevron Osteotomy
Bunion
Active, not recruitingPhase 3
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Postoperative Pain
Active, not recruiting
Early Weight-Bearing After the Lapiplasty Procedure
Hallux Valgus, Bunion

All Bunions trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation
ClinicalTrials.gov ID: NCT04398329
Acronym / sponsor ID: HTX-034-101
Conditions: Bunions, Postoperative Pain
Keywords: Analgesia, Bunionectomy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Heron TherapeuticsIndustry (pharma, biotech, devices)
Study start: 8 May 2020 (actual)
Primary completion: 15 Jul 2021 (actual)
Study completion: 15 Jul 2021 (actual)
First posted: 21 May 2020 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Phase 1b: HTX-034 Low Dose	Experimental	Drug: HTX-034 low dose, Device: Luer lock applicatorFixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
Phase 1b: HTX-034 High Dose	Experimental	Drug: HTX-034 high dose, Device: Luer lock applicatorIndividualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
Phase 2: HTX-034 Low Dose	Experimental	Drug: HTX-034 low dose, Device: Luer lock applicatorFixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
Phase 2: HTX-034 High Dose	Experimental	Drug: HTX-034 high dose, Device: Luer lock applicatorIndividualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
Phase 1b/2: Bupivacaine HCl	Active comparator	Drug: Bupivacaine HClBupivacaine HCl (without epinephrine) 0.5%: 50 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
Has an American Society of Anesthesiologists (ASA) 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.

Key exclusion criteria (20 listed)

Had contralateral foot bunionectomy in the past 3 months.
Has a planned concurrent surgical procedure.
Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
Has received or is taking a contraindicated or prohibited medications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HTX-034 low doseHTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg	Drug	Phase 1b: HTX-034 Low Dose, Phase 2: HTX-034 Low Dose
HTX-034 high doseHTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg	Drug	Phase 1b: HTX-034 High Dose, Phase 2: HTX-034 High Dose
Luer lock applicatorApplicator for instillation	Device	Phase 1b: HTX-034 High Dose, Phase 1b: HTX-034 Low Dose, Phase 2: HTX-034 High Dose, Phase 2: HTX-034 Low Dose
Bupivacaine HClBupivacaine HCl 50 mg	Drug	Phase 1b/2: Bupivacaine HCl

Primary outcome

Incidence of TEAEs in Phases 1b/2
Time frame: 42 days
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
AUC0-72 of Pain Scores
Time frame: through 72 hours
Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.

9 secondary outcomes

Cmax for HTX-034
Time frame: 29 days
Tmax for HTX-034
Time frame: 29 days
AUClast for HTX-034
Time frame: 29 days
AUCinf for HTX-034
Time frame: 22 days
t½ of HTX-034
Time frame: 22 days
Mean AUC of Pain Scores With Activity
Time frame: 7 days
Opioid Consumption
Time frame: 7 days
Proportion of Subjects Who Are Opioid-free
Time frame: After surgery (Day 1) through the Day 15 visit
Number of Participants With SAEs
Time frame: 42 days

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1b: HTX-034 Low Dose	12	11
Phase 1b: HTX-034 High Dose	13	13
Phase 2: HTX-034 Low Dose	12	11
Phase 2: HTX-034 High Dose	22	21
Phases 1b/2: Bupivacaine HCl	19	17

Primary outcome: Incidence of TEAEs in Phases 1b/2

Time frame: 42 days. Count of participants. Unit: Participants

Measure	Phases 1b/2: HTX-034 Low Dose n = 22	Phases 1b/2: HTX-034 High Dose n = 34	Phases 1b/2: Bupivacaine HCl n = 17
Value	17	23	11

Population analysed: HTX-034 Phase 1b and Phase 2 low dose and Phase 1b and Phase 2 high dose Arms/Groups and Bupivacaine HCI Arm/Group was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.

Primary outcome: AUC0-72 of Pain Scores

Time frame: through 72 hours. Mean (Standard Deviation). Unit: pain intensity score*hr

Measure	Phases 1b/2: HTX-034 Low Dose n = 22	Phases 1b/2: HTX-034 High Dose n = 34	Phases 1b/2: Bupivacaine HCl n = 17
Value	283.50 (168.148)	287.41 (144.247)	363.43 (150.177)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 42 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1b: HTX-034 Low Dose	0 of 11 (0%)	8 of 11 (72.7%)	0 of 11
Phase 1b: HTX-034 High Dose	0 of 13 (0%)	10 of 13 (76.9%)	0 of 13
Phase 2: HTX-034 Low Dose	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
Phase 2: HTX-034 High Dose	0 of 21 (0%)	13 of 21 (61.9%)	0 of 21
Phases 1b/2: Bupivacaine HCl	0 of 17 (0%)	11 of 17 (64.7%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Bunions

Not yet recruitingPhase 2
Postsurgical Analgesia After Unilateral Bunionectomy
Bunionectomy, Bunion
Not yet recruitingPhase 3
Phase 3 Bunionectomy Study
Postoperative Pain, Bunion
Active, not recruiting
LSTR in Chevron Osteotomy
Bunion
Active, not recruitingPhase 3
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Postoperative Pain
Active, not recruiting
Early Weight-Bearing After the Lapiplasty Procedure
Hallux Valgus, Bunion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HTX-034 low dose, HTX-034 high dose and Luer lock applicator in people with Bunions and Postoperative Pain, run by Heron Therapeutics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of TEAEs in Phases 1b/2 (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04398329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.