Postoperative PainPhase 2NCT02762929
Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
A Phase 2 study testing HTX-011A, HTX-011B and HTX-002 in people with Postoperative Pain and Bunions, run by Heron Therapeutics at 5 sites in United States.
Trial summary
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Bunions
- What is being tested?
- HTX-011A, HTX-011B and HTX-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2016to Mar 2017
- Phase
- Phase 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
- Be male or female 18 years of age or older
- Female subjects are eligible only if all of the following apply:
- Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
- Not lactating
- Not planning to become pregnant while participating in the study
- Be surgically sterile; or be at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or be practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study
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- Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
- Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
- Have the ability and be willing to comply with the study procedures.
- Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form
Who cannot join
- Unwilling to sign informed consent or not willing or able to complete all study procedures
- Have a contraindication or be allergic to any medication to be used during the trial period
- Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
- Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
- Have clinically significant renal or hepatic abnormalities: for example, AST or ALT > 3x ULN, creatinine > 2x ULN
- Have another pre-existing painful condition that may confound pain assessments
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- Have another surgery planned within 30 days of procedure
- Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
- Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of scheduled surgery for this study
- Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
- Subjects who are receiving oxygen therapy at the time of screening
- Have participated in a clinical trial within 30 days of planned surgery
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Anaheim, California, 92801
Study site
Bakersfield, California, 93311
Study site
Houston, Texas, 77027
Study site
Pasadena, Maryland, 21122
Study site
San Antonio, Texas, 78229
About this study
Official title: A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Read the detailed description
This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of each component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.
- Conditions
- Postoperative Pain, Bunions
- Being tested
- HTX-011A, Saline Placebo, HTX-011B, HTX-002, Bupivacaine HCl
- Keywords
- Analgesia, Bunionectomy
- Medical subject headings
- Pain, Postoperative, Bunion, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011ADrug
HTX-011A (bupivacaine/meloxicam), via injection.
Saline PlaceboBiological
Saline placebo via injection.
HTX-011BDrug
HTX-011B (bupivacaine/meloxicam), via injection or instillation.
HTX-002Drug
HTX-002, via injection.
Bupivacaine HClDrug
Bupivacaine HCI, via injection.
HTX-009Drug
HTX-009, via injection.
| Study group | Role | What they receive |
|---|---|---|
| HTX-011A: 200 mg | Experimental | HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection. Receives: Drug: HTX-011A |
| HTX-011B: 30 mg | Experimental | HTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection. Receives: Drug: HTX-011B |
| HTX-011B : 60 mg | Experimental | HTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation. Receives: Drug: HTX-011B |
| HTX-011B: 120 mg | Experimental | HTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation. Receives: Drug: HTX-011B |
| HTX-011B: 200 mg | Experimental | HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection. Receives: Drug: HTX-011B |
| Bupivacaine HCI | Active comparator | Bupivacaine HCI, 50 mg via injection. Receives: Drug: Bupivacaine HCl |
| Saline Placebo | Active comparator | Saline placebo via injection. Receives: Biological: Saline Placebo |
| HTX-002, 60 mg | Experimental | HTX- 002, 60 mg via injection. Receives: Drug: HTX-002 |
| HTX-002, 120 mg | Experimental | HTX-002, 120 mg via injection. Receives: Drug: HTX-002 |
| HTX-002, 200 mg | Experimental | HTX-002, 200 mg via injection. Receives: Drug: HTX-002 |
| HTX-009 | Experimental | HTX-009, 3.6 mg via injection. Receives: Drug: HTX-009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Summed Pain Intensity (SPI) Score Over 24 Hours
The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2*PI4+2*PI6+2*PI8+2*PI10+2*PI12+2*PI14+4*PI18+6*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2017
- Study completionMar 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762929
- Sponsor's protocol ID
- HTX-011-C2016-208
- Status last verified
- Feb 2026
- First submitted
- 2 May 2016
- Last updated
- 23 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2019 Dec 16:rapm-2019-100714. doi: 10.1136/rapm-2019-100714. Online ahead of print.
PubMed 31843865
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011, HTX-002, or HTX-009 for Postoperative Analgesia Following Bunionectomy
- ClinicalTrials.gov ID
- NCT02762929
- Acronym / sponsor ID
- HTX-011-C2016-208
- Conditions
- Postoperative Pain, Bunions
- Keywords
- Analgesia, Bunionectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
Detailed description
This study includes multiple formulations for formulation selection of the fixed-combination product and for the factorial design assessment of the contribution of each component. HTX-011A is the second formulation studied (HTX-011-49). HTX-011B is the final formulation studied (HTX-011-56), which was also included in subsequent Phase 2b and Phase 3 studies. For the factorial design assessment, HTX-002, a bupivacaine-only formulation in the same HTX-011 proprietary polymer, and HTX-009, a meloxicam-only formulation in the same HTX-011 proprietary polymer, were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| HTX-011A: 200 mg | Experimental | Drug: HTX-011AHTX-011A (bupivacaine/meloxicam), 200 mg/6 mg via injection. |
| HTX-011B: 30 mg | Experimental | Drug: HTX-011BHTX 011B (bupivacaine/meloxicam), 30 mg/0.9 mg via injection. |
| HTX-011B : 60 mg | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam) 60 mg/1.8 mg via injection or instillation. |
| HTX-011B: 120 mg | Experimental | Drug: HTX-011BHTX- 011B (bupivacaine/meloxicam), 120 mg/3.6 mg via injection or instillation. |
| HTX-011B: 200 mg | Experimental | Drug: HTX-011BHTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection. |
| Bupivacaine HCI | Active comparator | Drug: Bupivacaine HClBupivacaine HCI, 50 mg via injection. |
| Saline Placebo | Active comparator | Biological: Saline PlaceboSaline placebo via injection. |
| HTX-002, 60 mg | Experimental | Drug: HTX-002HTX- 002, 60 mg via injection. |
| HTX-002, 120 mg | Experimental | Drug: HTX-002HTX-002, 120 mg via injection. |
| HTX-002, 200 mg | Experimental | Drug: HTX-002HTX-002, 200 mg via injection. |
| HTX-009 | Experimental | Drug: HTX-009HTX-009, 3.6 mg via injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be male or female 18 years of age or older
- Female subjects are eligible only if all of the following apply:
- Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
- Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
Key exclusion criteria (12 listed)
- Unwilling to sign informed consent or not willing or able to complete all study procedures
- Have a contraindication or be allergic to any medication to be used during the trial period
- Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
- Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
- Have clinically significant renal or hepatic abnormalities: for example, AST or ALT > 3x ULN, creatinine > 2x ULN
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-011AHTX-011A (bupivacaine/meloxicam), via injection. | Drug | HTX-011A: 200 mg |
| Saline PlaceboSaline placebo via injection. | Biological | Saline Placebo |
| HTX-011BHTX-011B (bupivacaine/meloxicam), via injection or instillation. | Drug | HTX-011B : 60 mg, HTX-011B: 120 mg, HTX-011B: 200 mg, HTX-011B: 30 mg |
| HTX-002HTX-002, via injection. | Drug | HTX-002, 120 mg, HTX-002, 200 mg, HTX-002, 60 mg |
| Bupivacaine HClBupivacaine HCI, via injection. | Drug | Bupivacaine HCI |
| HTX-009HTX-009, via injection. | Drug | HTX-009 |
Primary outcome
Mean Summed Pain Intensity (SPI) Score Over 24 Hours
Time frame: 0-24 hours
The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 will be calculated by summing the Pain intensity (PI) score at the relevant time points weighted by the scheduled time duration since the prior PI assessment as follows: SPI0-24= PI1+PI2+2*PI4+2*PI6+2*PI8+2*PI10+2*PI12+2*PI14+4*PI18+6*PI24. Min = 0 (if PI=0 at every time) and Max = 240 (if PI=10 at every time).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31843865Ottoboni T, Quart B, Pawasauskas J, Dasta JF, Pollak RA, Viscusi ER. Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Reg Anesth Pain Med. 2019 Dec 16:rapm-2019-100714. doi: 10.1136/rapm-2019-100714. Online ahead of print.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTX-011A, HTX-011B and HTX-002 in people with Postoperative Pain and Bunions, run by Heron Therapeutics at 5 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 11 inclusion and 12 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 phase mean?
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 4 Oct 2023). 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?
Mean Summed Pain Intensity (SPI) Score Over 24 Hours (time frame: 0-24 hours). 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 NCT02762929, which also lists 1 linked publication.
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 23 Feb 2026.