AnalgesiaPhase 4NCT05109312
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
A Phase 4 study testing Bupivacaine Hydrochloride, HTX-011 and Luer lock applicator in people with Analgesia, run by Heron Therapeutics at 7 sites in United States.
Trial summary
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Bupivacaine Hydrochloride, HTX-011 and Luer lock applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 Oct 2021to Jun 2024
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Is scheduled to undergo a unilateral Total Shoulder Arthroplasty (TSA) or abdominoplasty.
Who cannot join
- Is undergoing a revision surgery.
- Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
- History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
- Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
- Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
- Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
Show all 14Show fewer
- Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
- Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
- Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
- Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
- Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Has undergone 3 or more surgeries within 12 months, other than for diagnostic procedures (eg, colonoscopy).
- Has a body mass index (BMI) >40 kg/m2.
- Had undergone prior abdominoplasty or major abdominal wall surgery.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
First Surgical Hospital
Bellaire, Texas, 77401
Legent Orthopedic Hospital
Carrollton, Texas, 75006
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
JBR Clinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240
Gulfcoast Research Institute
Sarasota, Florida, 34232
The Orthopaedic Center
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
- Conditions
- Analgesia
- Being tested
- Bupivacaine Hydrochloride, HTX-011, Luer lock applicator, Ibuprofen, Acetaminophen
- Keywords
- postoperative pain, total shoulder arthroplasty, abdominoplasty, multimodal analgesia
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
100 mg
Bupivacaine HydrochlorideDrug
125 mg
HTX-011Drug
400 mg
Luer lock applicatorDevice
Applicator for instillation
IbuprofenDrug
400 mg
AcetaminophenDrug
1 g
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 Cohort 1 | Experimental | HTX-011 + multimodal analgesic (MMA) regimen Receives: Drug: HTX-011; Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen |
| Treatment Group 2 Cohort 1 | Active comparator | Bupivacaine HCl + MMA Receives: Drug: Bupivacaine Hydrochloride; Drug: Ibuprofen; Drug: Acetaminophen |
| Treatment Group 1 Cohort 2 | Experimental | HTX-011 + MMA Receives: Drug: HTX-011; Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen |
| Treatment Group 2 Cohort 2 | Active comparator | Bupivacaine HCl + MMA Receives: Drug: Bupivacaine Hydrochloride; Drug: Ibuprofen; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs).
Measured: Through Day 15
Secondary outcomes (5)
Maximum concentration (Cmax) of bupivacaine and meloxicam
Measured: Through 144 hours
Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam
Measured: Through 144 hours
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam
Measured: Through 144 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam
Measured: Through 144 hours
Apparent terminal half-life (t½) of bupivacaine and meloxicam
Measured: Through 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start12 Oct 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In each cohort, subjects will be randomized in a 2:1 ratio to HTX-011 or bupivacaine HCl, respectively. All subjects will receive a scheduled postoperative non opioid multimodal analgesic (MMA) regimen.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heron Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109312
- Sponsor's protocol ID
- HTX-011-401
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures
- ClinicalTrials.gov ID
- NCT05109312
- Acronym / sponsor ID
- HTX-011-401
- Conditions
- Analgesia
- Keywords
- postoperative pain, total shoulder arthroplasty, abdominoplasty, multimodal analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Heron TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 5 Nov 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 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- In each cohort, subjects will be randomized in a 2:1 ratio to HTX-011 or bupivacaine HCl, respectively. All subjects will receive a scheduled postoperative non opioid multimodal analgesic (MMA) regimen.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 Cohort 1 | Experimental | Drug: HTX-011, Device: Luer lock applicator, Drug: Ibuprofen, Drug: AcetaminophenHTX-011 + multimodal analgesic (MMA) regimen |
| Treatment Group 2 Cohort 1 | Active comparator | Drug: Bupivacaine Hydrochloride, Drug: Ibuprofen, Drug: AcetaminophenBupivacaine HCl + MMA |
| Treatment Group 1 Cohort 2 | Experimental | Drug: HTX-011, Device: Luer lock applicator, Drug: Ibuprofen, Drug: AcetaminophenHTX-011 + MMA |
| Treatment Group 2 Cohort 2 | Active comparator | Drug: Bupivacaine Hydrochloride, Drug: Ibuprofen, Drug: AcetaminophenBupivacaine HCl + MMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- Is scheduled to undergo a unilateral Total Shoulder Arthroplasty (TSA) or abdominoplasty.
Key exclusion criteria (14 listed)
- Is undergoing a revision surgery.
- Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
- History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
- Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
- Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
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 Hydrochloride100 mg | Drug | Treatment Group 2 Cohort 1 |
| Bupivacaine Hydrochloride125 mg | Drug | Treatment Group 2 Cohort 2 |
| HTX-011400 mg | Drug | Treatment Group 1 Cohort 1, Treatment Group 1 Cohort 2 |
| Luer lock applicatorApplicator for instillation | Device | Treatment Group 1 Cohort 1, Treatment Group 1 Cohort 2 |
| Ibuprofen400 mg | Drug | Treatment Group 1 Cohort 1, Treatment Group 1 Cohort 2, Treatment Group 2 Cohort 1, Treatment Group 2 Cohort 2 |
| Acetaminophen1 g | Drug | Treatment Group 1 Cohort 1, Treatment Group 1 Cohort 2, Treatment Group 2 Cohort 1, Treatment Group 2 Cohort 2 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Through Day 15
5 secondary outcomes
Maximum concentration (Cmax) of bupivacaine and meloxicam
Time frame: Through 144 hours
Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam
Time frame: Through 144 hours
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam
Time frame: Through 144 hours
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam
Time frame: Through 144 hours
Apparent terminal half-life (t½) of bupivacaine and meloxicam
Time frame: Through 144 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Hydrochloride, HTX-011 and Luer lock applicator in people with Analgesia, run by Heron Therapeutics at 7 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 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 treatment-emergent adverse events (TEAEs). (time frame: Through Day 15). 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 26 Oct 2023.