Postoperative PainPhase 2NCT02504580
Pilot Herniorrhaphy Study for Postoperative Analgesia
A Phase 2 study testing HTX-011, HTX-002 and Bupivacaine HCI (Marcaine) in people with Postoperative Pain, run by Heron Therapeutics at 3 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- HTX-011, HTX-002 and Bupivacaine HCI (Marcaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 463 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to 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
- 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 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 and for 30 days from completion of the study
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- 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.
- Plan to undergo a unilateral inguinal herniorrhaphy
- 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 should they participate in the trial
- Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E)
- Have clinically significant renal or hepatic abnormalities (defined as an AST or ALT > 3x ULN, creatinine > 2x ULN)
- Have another painful condition that may confound pain assessments
Show all 14Show fewer
- Have another surgery planned within 30 days of procedure, or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with large scrotal component that would be difficult to reduce surgically
- 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 surgery
- Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
- Female subjects who are pregnant (positive pregnancy test at screening or on the day of surgery)
- Subjects who are receiving oxygen therapy at the time of screening
- Have participated in a clinical trial within 30 days of planned surgery
- Have a body mass index (BMI) > 39 kg/m2
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Anaheim, California, 92801
Study site
Houston, Texas, 77004
Study site
Houston, Texas, 77027
About this study
Official title: 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
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
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-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.
- Conditions
- Postoperative Pain
- Being tested
- HTX-011, Placebo, HTX-002, Bupivacaine HCI (Marcaine), HTX-011A
- 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-011Drug
HTX-011 (bupivacaine/meloxicam) by injection.
PlaceboDrug
Saline placebo by injection.
HTX-002Drug
HTX-002, by injection or instillation (pooled).
Bupivacaine HCI (Marcaine)Drug
Bupivacaine HCI (Marcaine) by injection.
HTX-011ADrug
HTX-011A (bupivacaine/meloxicam) by injection.
HTX-011BDrug
HTX-011B (bupivacaine/meloxicam) by injection, instillation or combination.
HTX-009Drug
HTX-009 by injection and instillation (combination).
| Study group | Role | What they receive |
|---|---|---|
| Part A, Cohort A | Experimental | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by injection. Receives: Drug: HTX-011 |
| Part A, Cohort B | Experimental | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg by injection. Receives: Drug: HTX-011 |
| Part A, Cohort C | Experimental | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by instillation. Receives: Drug: HTX-011 |
| Part A, Cohort D | Experimental | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by instillation. Receives: Drug: HTX-011 |
| Part A, Cohort E | Experimental | HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by injection and instillation (combination). Receives: Drug: HTX-011 |
| Part A, Cohort F | Placebo comparator | Saline placebo by injection. Receives: Drug: Placebo |
| Part B, Cohort A | Experimental | HTX-011A (bupivacaine/meloxicam), 200 mg/6 mg by injection. Receives: Drug: HTX-011A |
| Part B, Cohort B | Experimental | HTX-011A (bupivacaine/meloxicam) 400 mg12 mg by injection. Receives: Drug: HTX-011A |
| Part B, Cohort C | Experimental | HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by injection. Receives: Drug: HTX-011B |
| Part B, Cohort D | Experimental | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by injection. Receives: Drug: HTX-011B |
| Part B, Cohort E | Placebo comparator | Saline placebo by injection. Receives: Drug: Placebo |
| Part C, Cohort A | Experimental | HTX-002, 200 mg by injection or instillation. Receives: Drug: HTX-002 |
| Part B, Cohort F | Experimental | HTX-002, 400 mg by injection or instillation. Receives: Drug: HTX-002 |
| Part C, Cohort B | Experimental | HTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by instillation. Receives: Drug: HTX-011B |
| Part B, Cohort G | Experimental | HTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by instillation. Receives: Drug: HTX-011B |
| Part C, Cohort C | Placebo comparator | Saline placebo by instillation. Receives: Drug: Placebo |
| Part C, Cohort D | Active comparator | Bupivacaine HCI (Marcaine), 75 mg by injection. Receives: Drug: Bupivacaine HCI (Marcaine) |
| Part D, Cohort A | Experimental | HTX-011B (bupivacaine/meloxicam), 400 mg/13 mg via a combination of injection and instillation. Receives: Drug: HTX-011B |
| Part E, Cohort A | Experimental | HTX-009, 12 mg by injection and instillation (combination). Receives: Drug: HTX-009 |
| Part F, Cohort A | Experimental | HTX-011B (bupivacaine/meloxicam), 300 mg/9 mg by instillation. Receives: Drug: HTX-011B |
| Part F, Cohort B | Experimental | Bupivacaine HCI (Marcaine), 75 mg by injection. Receives: Drug: Bupivacaine HCI (Marcaine) |
| Part F, Cohort C | Placebo comparator | Saline placebo by injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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 posted22 Jul 2015 (estimated)
- Study startJul 2015
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 463 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
- NCT02504580
- Sponsor's protocol ID
- HTX-011-C2015-202
- Status last verified
- Feb 2026
- First submitted
- 16 Jul 2015
- 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, 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
- ClinicalTrials.gov ID
- NCT02504580
- Acronym / sponsor ID
- HTX-011-C2015-202
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Jul 2015 (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, 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
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-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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 22
| Arm | Type | Receives |
|---|---|---|
| Part A, Cohort A | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by injection. |
| Part A, Cohort B | Experimental | Drug: HTX-011HTX-011(bupivacaine/meloxicam), 400 mg/12 mg by injection. |
| Part A, Cohort C | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg by instillation. |
| Part A, Cohort D | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by instillation. |
| Part A, Cohort E | Experimental | Drug: HTX-011HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg by injection and instillation (combination). |
| Part A, Cohort F | Placebo comparator | Drug: PlaceboSaline placebo by injection. |
| Part B, Cohort A | Experimental | Drug: HTX-011AHTX-011A (bupivacaine/meloxicam), 200 mg/6 mg by injection. |
| Part B, Cohort B | Experimental | Drug: HTX-011AHTX-011A (bupivacaine/meloxicam) 400 mg12 mg by injection. |
| Part B, Cohort C | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by injection. |
| Part B, Cohort D | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by injection. |
| Part B, Cohort E | Placebo comparator | Drug: PlaceboSaline placebo by injection. |
| Part C, Cohort A | Experimental | Drug: HTX-002HTX-002, 200 mg by injection or instillation. |
| Part B, Cohort F | Experimental | Drug: HTX-002HTX-002, 400 mg by injection or instillation. |
| Part C, Cohort B | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 200 mg/6 mg by instillation. |
| Part B, Cohort G | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 400 mg/12 mg by instillation. |
| Part C, Cohort C | Placebo comparator | Drug: PlaceboSaline placebo by instillation. |
| Part C, Cohort D | Active comparator | Drug: Bupivacaine HCI (Marcaine)Bupivacaine HCI (Marcaine), 75 mg by injection. |
| Part D, Cohort A | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 400 mg/13 mg via a combination of injection and instillation. |
| Part E, Cohort A | Experimental | Drug: HTX-009HTX-009, 12 mg by injection and instillation (combination). |
| Part F, Cohort A | Experimental | Drug: HTX-011BHTX-011B (bupivacaine/meloxicam), 300 mg/9 mg by instillation. |
| Part F, Cohort B | Experimental | Drug: Bupivacaine HCI (Marcaine)Bupivacaine HCI (Marcaine), 75 mg by injection. |
| Part F, Cohort C | Placebo comparator | Drug: PlaceboSaline placebo by 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:
- Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
- 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.
- Plan to undergo a unilateral inguinal herniorrhaphy
Key exclusion criteria (14 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 should they participate in the trial
- Have American Society of Anesthesiologists (ASA) Physical Status classification system category 4 or greater (Appendix E)
- Have clinically significant renal or hepatic abnormalities (defined as an 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-011HTX-011 (bupivacaine/meloxicam) by injection. | Drug | Part A, Cohort A, Part A, Cohort B, Part A, Cohort C, Part A, Cohort D, Part A, Cohort E |
| PlaceboSaline placebo by injection. | Drug | Part A, Cohort F, Part B, Cohort E, Part C, Cohort C, Part F, Cohort C |
| HTX-002HTX-002, by injection or instillation (pooled). | Drug | Part B, Cohort F, Part C, Cohort A |
| Bupivacaine HCI (Marcaine)Bupivacaine HCI (Marcaine) by injection. | Drug | Part C, Cohort D, Part F, Cohort B |
| HTX-011AHTX-011A (bupivacaine/meloxicam) by injection. | Drug | Part B, Cohort A, Part B, Cohort B |
| HTX-011BHTX-011B (bupivacaine/meloxicam) by injection, instillation or combination. | Drug | Part B, Cohort C, Part B, Cohort D, Part B, Cohort G, Part C, Cohort B, Part D, Cohort A, Part F, Cohort A |
| HTX-009HTX-009 by injection and instillation (combination). | Drug | Part E, Cohort A |
Primary outcome
Mean Summed Pain Intensity (SPI) Score
Time frame: 24 hours
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).
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.
3 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-011, HTX-002 and Bupivacaine HCI (Marcaine) in people with Postoperative Pain, run by Heron Therapeutics at 3 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 14 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 3 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?
Mean Summed Pain Intensity (SPI) Score (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.