A Phase 2 interventional study of HTX-011 and Placebo in Postoperative Pain, sponsored by Heron Therapeutics. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Heron Therapeutics · Phase 2, Interventional, and Prevention
A Phase 2, Randomized, Pilot Study to Investigate the Safety, Efficacy, Pharmacokinetics and Bioavailability of HTX-011, HTX-002, or HTX-009 Administered Via Injection and/or Topical Application Following Unilateral Open Inguinal Herniorrhaphy
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-011 is the initial formulation studied (HTX-011-19). 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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 463 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative 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.
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)
Male:
o 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.
Exclusion Criteria:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by injection.
Drug: HTX-011
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg by injection.
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by instillation.
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by instillation.
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by injection and instillation (combination).
Drug: HTX-011
Saline placebo by injection.
Drug: Placebo
HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg by injection.
Drug: HTX-011A
HTX-011A (bupivacaine/meloxicam) 400 mg12 mg by injection.
Drug: HTX-011A
HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by injection.
Drug: HTX-011B
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by injection.
Drug: HTX-011B
Saline placebo by injection.
Drug: Placebo
HTX-002, 200 mg by injection or instillation.
Drug: HTX-002
HTX-002, 400 mg by injection or instillation.
Drug: HTX-002
HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by instillation.
Drug: HTX-011B
HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by instillation.
Drug: HTX-011B
Saline placebo by instillation.
Drug: Placebo
Bupivacaine HCI (Marcaine), 75 mg by injection.
Drug: Bupivacaine HCI (Marcaine)
HTX-011B (bupivacaine/meloxicam), 400 mg/13 mg via a combination of injection and instillation.
Drug: HTX-011B
HTX-009, 12 mg by injection and instillation (combination).
Drug: HTX-009
HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg by instillation.
Drug: HTX-011B
Bupivacaine HCI (Marcaine), 75 mg by injection.
Drug: Bupivacaine HCI (Marcaine)
Saline placebo by injection.
Drug: Placebo
Drug pages: Bupivacaine · Meloxicam
HTX-011 (bupivacaine/meloxicam) by injection.
Saline placebo by injection.
HTX-002, by injection or instillation (pooled).
Bupivacaine HCI (Marcaine) by injection.
HTX-011A (bupivacaine/meloxicam) by injection.
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
HTX-009 by injection and instillation (combination).
Mean Summed Pain Intensity (SPI) Score
Subjects assessed pain intensity for their current pain with the 11-point (0 to 10) Numeric Rating Scale NRS where "0" equated to "no pain" and "10" equated to "the worst pain imaginable". Pain intensity was assessed at rest (NRS-R) after the subject had been supine for a minimum of 5 minutes and with activity (NRS-A) sitting up from a supine position. The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 was 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).
Time frame: 24 hours
| Milestone | Part A, Cohort A: HTX-011 | Part A, Cohort B: HTX-011 | Part A, Cohort C: HTX-011 | Part A, Cohort D: HTX-011 | Part A, Cohort E: HTX-011 | Part A, Cohort F: Saline Placebo | Parts B/C/D/E/F/G: HTX-011A | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-011-002 | Parts B/C/D/E/F/G: HTX-009 | Parts B/C/D/E/F/G: Bupivacaine (Marcaine) | Parts B/C/D/E/F/G: Saline Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 19 | 17 | 16 | 20 | 17 | 18 | 40 | 131 | 52 | 18 | 32 | 83 |
| Completed | 18 | 16 | 16 | 18 | 16 | 17 | 39 | 129 | 52 | 18 | 32 | 81 |
| Not completed | 1 | 1 | 0 | 2 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 2 |
| Withdrew: Other | 1 | 0 | 0 | 2 | 1 | 1 | 1 | 2 | 0 | 0 | 0 | 2 |
| Withdrew: Subject refusal to continue | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Subjects assessed pain intensity for their current pain with the 11-point (0 to 10) Numeric Rating Scale NRS where "0" equated to "no pain" and "10" equated to "the worst pain imaginable". Pain intensity was assessed at rest (NRS-R) after the subject had been supine for a minimum of 5 minutes and with activity (NRS-A) sitting up from a supine position. The SPI is derived by summing the pain intensity score weighted by the scheduled time duration. SPI0-24 was 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).
| Units on a scale | HTX-011: 200 mg | HTX-011: 400 mg | HTX-011A: 200 mg | HTX-011A: 400 mg | HTX-011B: 200 mg | HTX-011B: 300 mg | HTX-011B: 400 mg | HTX-002: 200 mg | HTX-002: 400 mg | HTX-009: 12 mg | Saline Placebo | Bupivacaine HCI |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean Summed Pain Intensity (SPI) Score | 83.71 ± 45.996 | 77.63 ± 40.679 | 95.24 ± 50.135 | 89.28 ± 59.403 | 97.16 ± 49.093 | 73.81 ± 50.572 | 86.61 ± 40.091 | 99.82 ± 41.433 | 99.53 ± 45.415 | 118.22 ± 26.399 | 121.93 ± 48.239 | 108.72 ± 37.552 |
Collected over 28 Days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A, Cohorts A, B C, D, E: HTX-011 | 0/89 (0%) | 1/89 (1.1%) | 56/89 (62.9%) |
| Part A: Saline Placebo | 0/18 (0%) | 1/18 (5.6%) | 13/18 (72.2%) |
| Part B/C/D/E/F/G: Part B/C/D/E/F/G: HTX-011A | 0/39 (0%) | 0/39 (0%) | 20/39 (51.3%) |
| Part B/C/D/E/F/G: Part B/C/D/E/F/G: HTX-002 | 0/51 (0%) | 0/51 (0%) | 28/51 (54.9%) |
| Parts B/C/D/E/F/G: HTX-011B | 0/131 (0%) | 2/131 (1.5%) | 85/131 (64.9%) |
| Parts B/C/D/E/F/G: HTX-011-009 | 0/18 (0%) | 2/18 (11.1%) | 13/18 (72.2%) |
| Parts B/C/D/E/F/G: Bupivacaine HCI (Marcaine) | 0/32 (0%) | 1/32 (3.1%) | 19/32 (59.4%) |
| Parts B/C/D/E/F/G: Saline Placebo | 0/85 (0%) | 1/85 (1.2%) | 52/85 (61.2%) |
| Event | Part A, Cohorts A, B C, D, E: HTX-011 | Part A: Saline Placebo | Part B/C/D/E/F/G: Part B/C/D/E/F/G: HTX-011A | Part B/C/D/E/F/G: Part B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-011-009 | Parts B/C/D/E/F/G: Bupivacaine HCI (Marcaine) | Parts B/C/D/E/F/G: Saline Placebo |
|---|---|---|---|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/89 | 0/18 | 0/39 | 0/51 | 0/131 | 1/18 | 0/32 | 0/85 |
| CellulitisInfections and infestations | 0/89 | 0/18 | 0/39 | 0/51 | 0/131 | 1/18 | 0/32 | 0/85 |
| Non-cardiac chest painGeneral disorders | 0/89 | 1/18 | 0/39 | 0/51 | 0/131 | 0/18 | 0/32 | 0/85 |
| Scrotal haematomaInjury, poisoning and procedural complications | 0/89 | 0/18 | 0/39 | 0/51 | 0/131 | 0/18 | 1/32 | 0/85 |
| Cellulitis of male external genital organInfections and infestations | 0/89 | 0/18 | 0/39 | 0/51 | 0/131 | 0/18 | 0/32 | 1/85 |
| Vestibular neuronitisInfections and infestations | 1/89 | 0/18 | 0/39 | 0/51 | 0/131 | 0/18 | 0/32 | 0/85 |
| PresyncopeNervous system disorders | 0/89 | 0/18 | 0/39 | 0/51 | 1/131 | 0/18 | 0/32 | 0/85 |
| Deep vein thrombosisVascular disorders | 0/89 | 0/18 | 0/39 | 0/51 | 1/131 | 0/18 | 0/32 | 0/85 |
| Event | Part A, Cohorts A, B C, D, E: HTX-011 | Part A: Saline Placebo | Part B/C/D/E/F/G: Part B/C/D/E/F/G: HTX-011A | Part B/C/D/E/F/G: Part B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-011-009 | Parts B/C/D/E/F/G: Bupivacaine HCI (Marcaine) | Parts B/C/D/E/F/G: Saline Placebo |
|---|---|---|---|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 28/89 | 6/18 | 9/39 | 14/51 | 41/131 | 8/18 | 8/32 | 28/85 |
| NauseaGastrointestinal disorders | 8/89 | 6/18 | 2/39 | 10/51 | 30/131 | 4/18 | 6/32 | 19/85 |
| HeadacheNervous system disorders | 10/89 | 0/18 | 3/39 | 6/51 | 24/131 | 4/18 | 4/32 | 7/85 |
| TachycardiaCardiac disorders | 4/89 | 4/18 | 4/39 | 0/51 | 7/131 | 2/18 | 2/32 | 5/85 |
| VomitingGastrointestinal disorders | 4/89 | 4/18 | 0/39 | 0/51 | 7/131 | 2/18 | 1/32 | 5/85 |
| HypertensionVascular disorders | 7/89 | 3/18 | 1/39 | 0/51 | 2/131 | 0/18 | 1/32 | 5/85 |
| BradycardiaCardiac disorders | 10/89 | 1/18 | 2/39 | 1/51 | 7/131 | 2/18 | 2/32 | 6/85 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/89 | 2/18 | 0/39 | 0/51 | 1/131 | 0/18 | 1/32 | 0/85 |
| PruritusSkin and subcutaneous tissue disorders | 1/89 | 2/18 | 0/39 | 0/51 | 2/131 | 0/18 | 1/32 | 2/85 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/89 | 2/18 | 0/39 | 1/51 | 0/131 | 0/18 | 0/32 | 1/85 |
Study HTX-011-202 included multiple study parts, various study drugs, formulations, and administration techniques. It was pre-specified in the SAP to pool different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. We pooled different doses of the same study drug within study parts for Participant Flow, Baseline Characteristics, and AEs. However for Outcome Measures, different doses of study drugs were presented separately.
| Age, Continuous(years) | Part A, Cohorts A, B C, D, E: HTX-011 | Part A, Cohort F: Saline Placebo | Part B/C/D/E/F/G: HTX-011A | Parts B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-009 | Parts B/C/D/E/F/G: Bupivacaine (Marcaine | Parts A/B/C/D/E/F/G: Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 45.4 ± 12.56 | 46.5 ± 13.99 | 50.8 ± 9.99 | 46.8 ± 14.26 | 45.6 ± 13.30 | 49.8 ± 10.73 | 41.7 ± 12.74 | 46.0 ± 12.40 | 46.1 ± 12.82 |
| Sex: Female, Male(Participants) | Part A, Cohorts A, B C, D, E: HTX-011 | Part A, Cohort F: Saline Placebo | Part B/C/D/E/F/G: HTX-011A | Parts B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-009 | Parts B/C/D/E/F/G: Bupivacaine (Marcaine | Parts A/B/C/D/E/F/G: Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 5 | 0 | 0 | 2 | 2 | 1 | 1 | 1 | 12 |
| Male | 84 | 18 | 39 | 49 | 129 | 17 | 31 | 84 | 451 |
| Ethnicity (NIH/OMB)(Participants) | Part A, Cohorts A, B C, D, E: HTX-011 | Part A, Cohort F: Saline Placebo | Part B/C/D/E/F/G: HTX-011A | Parts B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-009 | Parts B/C/D/E/F/G: Bupivacaine (Marcaine | Parts A/B/C/D/E/F/G: Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 42 | 7 | 13 | 21 | 57 | 4 | 11 | 36 | 191 |
| Not Hispanic or Latino | 47 | 11 | 26 | 30 | 74 | 14 | 21 | 49 | 272 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Part A, Cohorts A, B C, D, E: HTX-011 | Part A, Cohort F: Saline Placebo | Part B/C/D/E/F/G: HTX-011A | Parts B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-009 | Parts B/C/D/E/F/G: Bupivacaine (Marcaine | Parts A/B/C/D/E/F/G: Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 3 |
| Asian | 0 | 0 | 0 | 0 | 4 | 0 | 1 | 1 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 12 | 0 | 6 | 6 | 11 | 4 | 4 | 14 | 57 |
| White | 77 | 18 | 33 | 45 | 112 | 13 | 27 | 70 | 395 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Part A, Cohorts A, B C, D, E: HTX-011 | Part A, Cohort F: Saline Placebo | Part B/C/D/E/F/G: HTX-011A | Parts B/C/D/E/F/G: HTX-002 | Parts B/C/D/E/F/G: HTX-011B | Parts B/C/D/E/F/G: HTX-009 | Parts B/C/D/E/F/G: Bupivacaine (Marcaine | Parts A/B/C/D/E/F/G: Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 89 | 18 | 39 | 51 | 131 | 18 | 32 | 85 | 463 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2015 to primary completion in Mar 2017, 20 months.
Results were first posted in Oct 2023, 6 years 7 months after primary completion. A results delay was requested in Jun 2018.
Of 49 industry-sponsored phase 2 interventional studies under Pain, Postoperative, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 20 months is above that.
Counting every sponsor, half of 140 studies reached it within 12 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 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 · HTX-002 · HTX-011A · HTX-011B