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

• Sponsor: Heron Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06109428
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site: 15
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Drug: HTX-011; Drug: Bupivacaine Hydrochloride; Drug: Ibuprofen; Drug: Acetaminophen; Device: Luer lock applicator	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Abdominoplasty (Cohort 2)
• Actual Study Start Date: Oct 12, 2021
• Actual Primary Completion Date: Mar 29, 2022
• Actual Study Completion Date: Apr 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group 1 Cohort 2 HTX-011 + MMA regimen	Drug: HTX-011; 400 mg; Drug: Ibuprofen; 400 mg; Drug: Acetaminophen; 1 g; Device: Luer lock applicator; Applicator for instillation
Active Comparator: Treatment Group 2 Cohort 2 Bupivacaine HCl + MMA regimen	Drug: Bupivacaine Hydrochloride; 125 mg; Drug: Ibuprofen; 400 mg; Drug: Acetaminophen; 1 g

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events (TEAEs). [Through Day 15]

Secondary Outcome Measures

1. Maximum concentration (Cmax) of bupivacaine and meloxicam [Through 144 hours]

2. Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam [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 [Through 144 hours]

4. Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam [Through 144 hours]

5. Apparent terminal half-life (t½) of bupivacaine and meloxicam [Through 144 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.

• Is scheduled to undergo abdominoplasty.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Surgical Hospital	Bellaire	Texas	United States	77401
2	Endeavor Clinical Trials, LLC	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Heron Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heron Therapeutics
• ClinicalTrials.gov Identifier: NCT06109428
• Other Study ID Numbers: HTX-011-401 (Cohort 2)
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Heron Therapeutics: postoperative pain; abdominoplasty; multimodal analgesia
• Additional relevant MeSH terms: Acetaminophen; Ibuprofen; Bupivacaine

Study Results

No Results Posted as of Oct 31, 2023