Postoperative PainPhase 2NCT02689258
Evaluation of the Efficacy and Safety of HTX-011 for Postoperative Analgesia Following Abdominoplasty Surgery
A Phase 2 study testing HTX-011B, HTX-011A and HTX-002 in people with Postoperative Pain, run by Heron Therapeutics at 8 sites in United States.
Trial summary
A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- HTX-011B, HTX-011A and HTX-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Feb 2016to Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be considered eligible to participate in the study:
- Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol
- Be American Society of Anesthesiology (ASA) physical Class I or II
- Subjects 18 years of age or older
- Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT < 3 x ULN, and/or creatinine < 2 x ULN are acceptable.
- Have a body mass index ≤ 30 kg/m2
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- 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 tests at screening and negative urine pregnancy test before surgery)
- Not lactating
- Not planning to become pregnant during the study
- Be surgically sterile; or at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or is 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
- 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
- Does NOT have, as determined by the investigator or the study's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
- Must be able to understand study procedures and be willing to comply and give informed consent for the conduct of all study procedures, using an IRB approved consent
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participating in the study:
- Have a contraindication or be allergic to any medication to be used during the trial period
- Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of post-operative pain
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants
- 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 surgery
- Previous abdominal surgery, as determined by the investigator, that would preclude participation in the study
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- Subjects that require liposuction as part of the abdominoplasty procedure in Part A of the protocol
- Subjects that are to have ancillary procedures performed during the abdominoplasty surgery that are unrelated to the abdominal area (breast reduction, breast augmentation, etc.)
- Subjects unable to discontinue medications that have not been at a stable dose for at least 14 days prior to the scheduled abdominoplasty procedure and before dosing with investigational product
- Subjects taking the following medications; anticonvulsants, sedatives (including benzodiazepines) corticosteroids (by any means of administration), nonsteroidal anti-inflammatory drugs (NSAIDS) within 24 hours of study drug dosing, morphine, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin-norepinephrine reuptake inhibitors (SNRIs). Gabapentin and pregabalin are not permitted
- Have a known or suspected history of alcohol or drug abuse
- Have positive results on the alcohol breath test indicative of alcohol abuse or urine drug screen indicative of illicit drug use (unless results can be explained by a current prescription or acceptable over-the-counter medication at screening as determined by the investigator). The urine drug screen prior to surgery must be negative
- Have evidence of a clinically significant 12-lead ECG abnormality according to the judgment of the investigator
- Have received any investigational product within 30 days before start of study
- Have previously received HTX-011 in clinical trials
- Experiences a clinically significant event during surgery prior to the administration of the investigational product (e.g., excessive bleeding, hemodynamic instability) that would render the subject medically unstable, complicate their post-surgical course, or significantly increase the risk of study drug administration as per the judgment of the investigator. This will result in the subject being reported as randomized, not treated.
- Subjects with sleep apnea or are on home continuous positive airway pressure (CPAP)
- Subjects who are receiving oxygen therapy at the time of screening
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Bellaire, Texas, 77401
Study site
Houston, Texas, 77004
Study site
Houston, Texas, 77019
Study site
Houston, Texas, 77027
Study site
Pasadena, California, 91105
Study site
Pasadena, Maryland, 21122
Study site
Phoenix, Arizona, 85023
Study site
Plano, Texas, 75093
About this study
Official title: A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
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 the bupivacaine 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 was evaluated.
- Conditions
- Postoperative Pain
- Being tested
- HTX-011B, Placebo, HTX-011A, HTX-002, Bupivicaine HCl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTX-011BDrug
HTX- 011B (bupivacaine/meloxicam) via injection
PlaceboDrug
Saline placebo via injection
HTX-011ADrug
HTX- 011A (bupivacaine/meloxicam) via injection
HTX-002Drug
HTX-002 via combination
Bupivicaine HClDrug
Bupivacaine HCl via injection
| Study group | Role | What they receive |
|---|---|---|
| Part A, Cohort A: HTX-011A | Experimental | HTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection Receives: Drug: HTX-011A |
| Parts A and B, Cohort B: Saline Placebo | Placebo comparator | Saline placebo via injection Receives: Drug: Placebo |
| Part A, Cohort C: HTX-011B | Experimental | HTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection Receives: Drug: HTX-011B |
| Part A, Cohort D: HTX-011B | Experimental | HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection Receives: Drug: HTX-011B |
| Part A, Cohort E: HTX-011B | Experimental | HTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination Receives: Drug: HTX-011B |
| Part A, Cohort F: HTX-011B | Experimental | HTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection Receives: Drug: HTX-011B |
| Part B, Cohort A: HTX-002 | Experimental | HTX-002, 400 mg via combination Receives: Drug: HTX-002 |
| Part C, Cohort A: HTX-011B | Experimental | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation Receives: Drug: HTX-011B |
| Part C, Cohort B: HTX-011B | Experimental | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination Receives: Drug: HTX-011B |
| Part C, Cohort C: HTX-011B | Experimental | HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination Receives: Drug: HTX-011B |
| Part C, Cohort D: Bupivacaine HCI | Active comparator | Bupivacaine HCl, 100 mg via injection Receives: Drug: Bupivicaine HCl |
| Part C, Cohort E: Saline Placebo | Placebo comparator | Saline placebo via injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Scores Collected 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: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start23 Feb 2016
- Primary completionMar 2017
- Study completionApr 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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 277 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
- NCT02689258
- Sponsor's protocol ID
- HTX-011-C2015-203
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2016
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Controlled Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
- ClinicalTrials.gov ID
- NCT02689258
- Acronym / sponsor ID
- HTX-011-C2015-203
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Feb 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 Evaluation of the Efficacy and Safety of HTX-011 or HTX-002 for Post-Operative Analgesia Following Abdominoplasty Surgery
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 the bupivacaine 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 was evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A, Cohort A: HTX-011A | Experimental | Drug: HTX-011AHTX- 011A (bupivacaine/meloxicam), 200 mg/6 mg via injection |
| Parts A and B, Cohort B: Saline Placebo | Placebo comparator | Drug: PlaceboSaline placebo via injection |
| Part A, Cohort C: HTX-011B | Experimental | Drug: HTX-011BHTX- 011B (bupivacaine/meloxicam), 200 mg/6 mg via injection |
| Part A, Cohort D: HTX-011B | Experimental | Drug: HTX-011BHTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via injection |
| Part A, Cohort E: HTX-011B | Experimental | Drug: HTX-011BHTX- 011B (bupivacaine/meloxicam), 400 mg/12 mg via combination |
| Part A, Cohort F: HTX-011B | Experimental | Drug: HTX-011BHTX- 011B (bupivacaine/meloxicam), 600 mg/18 mg via injection |
| Part B, Cohort A: HTX-002 | Experimental | Drug: HTX-002HTX-002, 400 mg via combination |
| Part C, Cohort A: HTX-011B | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via instillation |
| Part C, Cohort B: HTX-011B | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 400 mg/12 mg via combination |
| Part C, Cohort C: HTX-011B | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 300 mg/9 mg via combination |
| Part C, Cohort D: Bupivacaine HCI | Active comparator | Drug: Bupivicaine HClBupivacaine HCl, 100 mg via injection |
| Part C, Cohort E: Saline Placebo | Placebo comparator | Drug: PlaceboSaline placebo via injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must meet all of the following criteria to be considered eligible to participate in the study:
- Be scheduled to undergo abdominoplasty surgery that is amenable to treatment with a long acting local anesthetic as per the anesthesia protocol
- Be American Society of Anesthesiology (ASA) physical Class I or II
- Subjects 18 years of age or older
- Have clinical laboratory values that are within normal limits (WNL); subjects with AST/ALT < 3 x ULN, and/or creatinine < 2 x ULN are acceptable.
Key exclusion criteria (18 listed)
- Subjects who meet any of the following criteria will be excluded from participating in the study:
- Have a contraindication or be allergic to any medication to be used during the trial period
- Have another painful physical condition that, in the opinion of the investigator, may confound the assessments of post-operative pain
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants
- 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 surgery
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-011BHTX- 011B (bupivacaine/meloxicam) via injection | Drug | Part A, Cohort C: HTX-011B, Part A, Cohort D: HTX-011B, Part A, Cohort E: HTX-011B, Part A, Cohort F: HTX-011B, Part C, Cohort A: HTX-011B, Part C, Cohort B: HTX-011B, Part C, Cohort C: HTX-011B |
| PlaceboSaline placebo via injection | Drug | Part C, Cohort E: Saline Placebo, Parts A and B, Cohort B: Saline Placebo |
| HTX-011AHTX- 011A (bupivacaine/meloxicam) via injection | Drug | Part A, Cohort A: HTX-011A |
| HTX-002HTX-002 via combination | Drug | Part B, Cohort A: HTX-002 |
| Bupivicaine HClBupivacaine HCl via injection | Drug | Part C, Cohort D: Bupivacaine HCI |
Primary outcome
Summed Pain Intensity Scores Collected Over 24 Hours
Time frame: 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 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
8 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-011B, HTX-011A and HTX-002 in people with Postoperative Pain, run by Heron Therapeutics at 8 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 14 inclusion and 18 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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?
Summed Pain Intensity Scores Collected Over 24 Hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.