Post-Operative PainPhase 2NCT04911062
HTX-011 in Spinal Surgery
A Phase 2 study testing Bupivacaine HCI without epinephrine, HTX-011 and Luer Lock Applicator in people with Post-Operative Pain and Lumbar Laminectomy, run by Heron Therapeutics at 12 sites in United States.
Trial summary
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Pain, Lumbar Laminectomy
- What is being tested?
- Bupivacaine HCI without epinephrine, HTX-011 and Luer Lock Applicator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 12 sitesUnited States
- Study dates
- 7 Apr 2022to 26 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
- Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
Who cannot join
- Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
- Has functioning intrathecal drug pump or spinal cord stimulator.
- Opioid use for most days within the last 3 months.
- Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery.
- Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
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- Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.
- Has impaired balance and is at risk of falling.
- Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
- Has undergone 3 or more surgeries within 12 months.
- Has a known history of glucose-6-phosphate dehydrogenase deficiency.
- Has History of liver cirrhosis, having an aspartate aminotransferase >3 × the upper limit of normal (ULN), or having an alanine aminotransferase >3 × ULN.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Austin Neurosurgeons
Austin, Texas, 78746
First Surgical Hospital
Bellaire, Texas, 77401
The Ohio State University Wexner Medical Center - University Hospital
Columbus, Ohio, 43210
M3 Emerging Medical Research, LLC
Durham, North Carolina, 27704
Houston Heights Hospital
Houston, Texas, 77008
Lotus Clinical Research, LLC
Pasadena, California, 91105
Arizona Research Center
Phoenix, Arizona, 85053
JBR Clinical Research
Salt Lake City, Utah, 84107
South Texas Spine & Surgical Center
San Antonio, Texas, 78258
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Overlook Medical Center
Summit, New Jersey, 07901
Kansas Spine and Specialty Hospital
Wichita, Kansas, 67226
About this study
Official title: A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
- Conditions
- Post-Operative Pain, Lumbar Laminectomy
- Being tested
- Bupivacaine HCI without epinephrine, HTX-011, Luer Lock Applicator
- Keywords
- postoperative pain, local anesthetic, lumbar laminectomy, lumbar decompression
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HCI without epinephrineDrug
100 mg administered via injection into the surgical site.
HTX-011Drug
HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.
Luer Lock ApplicatorDevice
Applicator for instillation.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Bupivacaine HCl | Experimental | Bupivacaine HCl without epinephrine, via injection into the surgical site. Receives: Drug: Bupivacaine HCI without epinephrine |
| Cohort 2: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam) via application into the surgical site. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
| Cohort 3: HTX-011 | Experimental | HTX-011 (bupivacaine/meloxicam) via application into the surgical site. Receives: Drug: HTX-011; Device: Luer Lock Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events
Measured: From the time the subject signs the ICF through the Day 29 Visit
Secondary outcomes (5)
Maximum Observed Plasma Concentration (Cmax)
Measured: Baseline through 120 hours
Time of occurrence of maximum concentration (Tmax)
Measured: Baseline through 120 hours
Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)
Measured: Baseline through 120 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Measured: Baseline through 120 hours
Apparent terminal half-life (t½)
Measured: Baseline through 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start7 Apr 2022
- Primary completion29 Jul 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT04911062
- Sponsor's protocol ID
- HTX-011-221
- Status last verified
- Jun 2023
- First submitted
- 27 May 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Two-Part, Multicenter Study of HTX-011 in Spinal Surgery
- ClinicalTrials.gov ID
- NCT04911062
- Acronym / sponsor ID
- HTX-011-221
- Conditions
- Post-Operative Pain, Lumbar Laminectomy
- Keywords
- postoperative pain, local anesthetic, lumbar laminectomy, lumbar decompression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Bupivacaine HCl | Experimental | Drug: Bupivacaine HCI without epinephrineBupivacaine HCl without epinephrine, via injection into the surgical site. |
| Cohort 2: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorHTX-011 (bupivacaine/meloxicam) via application into the surgical site. |
| Cohort 3: HTX-011 | Experimental | Drug: HTX-011, Device: Luer Lock ApplicatorHTX-011 (bupivacaine/meloxicam) via application into the surgical site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
- Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.
Key exclusion criteria (12 listed)
- Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
- Has functioning intrathecal drug pump or spinal cord stimulator.
- Opioid use for most days within the last 3 months.
- Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled 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 |
|---|---|---|
| Bupivacaine HCI without epinephrine100 mg administered via injection into the surgical site. | Drug | Cohort 1: Bupivacaine HCl |
| HTX-011HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site. | Drug | Cohort 2: HTX-011, Cohort 3: HTX-011 |
| Luer Lock ApplicatorApplicator for instillation. | Device | Cohort 2: HTX-011, Cohort 3: HTX-011 |
Primary outcome
Incidence of Serious Adverse Events
Time frame: From the time the subject signs the ICF through the Day 29 Visit
5 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Baseline through 120 hours
Time of occurrence of maximum concentration (Tmax)
Time frame: Baseline through 120 hours
Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)
Time frame: Baseline through 120 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Time frame: Baseline through 120 hours
Apparent terminal half-life (t½)
Time frame: Baseline through 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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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.
12 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 Bupivacaine HCI without epinephrine, HTX-011 and Luer Lock Applicator in people with Post-Operative Pain and Lumbar Laminectomy, run by Heron Therapeutics at 12 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 2 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Serious Adverse Events (time frame: From the time the subject signs the ICF through the Day 29 Visit). 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 12 Jun 2023.