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Local Anesthetic/Nonsteroidal Anti-inflammatory Drug (NSAID)

HTX-011 for Pain Relief After Surgery

Phase 4
Waitlist Available
Research Sponsored by Heron Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 144 hours
Awards & highlights

Study Summary

This trial tests a new drug (HTX-011) against an existing one (bupivacaine HCl) for shoulder and tummy surgery.

Who is the study for?
This trial is for individuals scheduled for a unilateral Total Shoulder Arthroplasty or abdominoplasty, with an ASA Physical Status of I-III. Exclusions include recent NSAID use, prior surgeries within specific timeframes, high BMI (>40 kg/m2), drug abuse history, active COVID-19 infection, certain medication use close to surgery, and known allergies to study drugs.Check my eligibility
What is being tested?
The study tests HTX-011 against bupivacaine HCl in patients undergoing shoulder replacement or tummy tuck surgeries. It's randomized and blinded; participants won't know which treatment they receive. The goal is to compare pain relief effectiveness between the two treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to local anesthetics like bupivacaine (e.g., numbness, tingling), NSAIDs (e.g., stomach issues, allergic reactions), acetaminophen (e.g., liver damage at high doses), and general post-surgical risks such as infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 144 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 144 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs).
Secondary outcome measures
Apparent terminal half-life (t½) of bupivacaine and meloxicam
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration (AUClast) of bupivacaine and meloxicam
+2 more

Side effects data

From 2018 Phase 3 trial • 418 Patients • NCT03237481
18%
Nausea
17%
Constipation
15%
Dizziness
13%
Headache
9%
Bradycardia
9%
Dysgeusia
8%
Skin odour abnormal
4%
Tremor
4%
Vomiting
2%
Tinnitus
1%
Incision site haematoma
1%
Chronic obstructive pulmonary disease
1%
Gamma-glutamyltransferase increase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group 1: HTX-011
Treatment Group 2: Bupivacaine HCI
Treatment Group 3: Saline Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group 1 Cohort 2Experimental Treatment4 Interventions
HTX-011 + MMA
Group II: Treatment Group 1 Cohort 1Experimental Treatment4 Interventions
HTX-011 + multimodal analgesic (MMA) regimen
Group III: Treatment Group 2 Cohort 2Active Control3 Interventions
Bupivacaine HCl + MMA
Group IV: Treatment Group 2 Cohort 1Active Control3 Interventions
Bupivacaine HCl + MMA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved
Acetaminophen
FDA approved
HTX-011
2019
Completed Phase 4
~2390
Luer lock applicator
2019
Completed Phase 4
~320

Find a Location

Who is running the clinical trial?

Heron TherapeuticsLead Sponsor
27 Previous Clinical Trials
6,096 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
2021. "A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05109312.
~3 spots leftby Jun 2024
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