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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06109415
Other study ID # HTX-011-401 (Cohort 1)
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 20, 2021
Est. completion date July 29, 2022

Study information

Verified date October 2023
Source Heron Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 29, 2022
Est. primary completion date July 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III. - Is scheduled to undergo a unilateral Total Shoulder Arthroplasty. 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.

Study Design


Intervention

Drug:
HTX-011
400 mg
Bupivacaine Hydrochloride
100 mg
Ibuprofen
400 mg
Acetaminophen
1 g
Device:
Luer lock applicator
Applicator for instillation

Locations

Country Name City State
United States First Surgical Hospital Bellaire Texas
United States Legent Orthopedic Hospital Carrollton Texas
United States Center for Orthopaedic Reconstruction and Excellence Jenks Oklahoma
United States Woodland International Research Group, LLC Little Rock Arkansas
United States JBR Clinical Research Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs). Through Day 15
Secondary Maximum concentration (Cmax) of bupivacaine and meloxicam Through 144 hours
Secondary Time of occurrence of maximum concentration (Tmax) of bupivacaine and meloxicam Through 144 hours
Secondary 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
Secondary Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of bupivacaine and meloxicam Through 144 hours
Secondary Apparent terminal half-life (t½) of bupivacaine and meloxicam Through 144 hours
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