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CompletedNCT06109428Updated Oct 31, 2023

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE

A Phase 4 interventional study of HTX-011 and Bupivacaine Hydrochloride in Analgesia, sponsored by Heron Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Heron Therapeutics · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2022, 4 years 6 months ago, and no results have been posted to the registry.
  • Registered 2 years after the study started (first participant enrolled Oct 2021, registered Oct 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing abdominoplasty (Cohort 2).

02

Conditions studied

  • Analgesia

Keywords

  • postoperative pain
  • abdominoplasty
  • multimodal analgesia
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's enrollment of 30 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

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, 8 (57%) have results posted.

Browse Heron Therapeutics studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
  • Is scheduled to undergo abdominoplasty.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Treatment Group 1 Cohort 2

    HTX-011 + MMA regimen

    Drug: HTX-011 · Drug: Ibuprofen · Drug: Acetaminophen · Device: Luer lock applicator

  • Active comparator
    Treatment Group 2 Cohort 2

    Bupivacaine HCl + MMA regimen

    Drug: Bupivacaine Hydrochloride · Drug: Ibuprofen · Drug: Acetaminophen

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs).

    Time frame: Through Day 15

Secondary outcomes

  1. Maximum concentration (Cmax) of bupivacaine and meloxicam

    Time frame: Through 144 hours

  2. Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam

    Time frame: Through 144 hours

  3. 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

  4. Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam

    Time frame: Through 144 hours

  5. Apparent terminal half-life (t½) of bupivacaine and meloxicam

    Time frame: Through 144 hours

07

Study locations

2 sites
  • First Surgical Hospital
    Bellaire, Texas 77401, United States
  • Endeavor Clinical Trials, LLC
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Mar 2022, 5 months.

Of 83 phase 4 interventional studies under Agnosia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 29. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2023
First posted
Oct 31, 2023
StartActual
Oct 12, 2021
Primary completionActual
Mar 29, 2022
CompletionActual
Apr 7, 2022
Last update
Oct 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06109428
Lead sponsor
Heron Therapeutics
Responsible party
Sponsor
First posted
Oct 31, 2023
Start date
Oct 12, 2021
Primary completion
Mar 29, 2022
Completion
Apr 7, 2022
Last update
Oct 31, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bupivacaine · Meloxicam

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