A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.
Public ClinicalTrials.gov record NCT06109415. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Total Shoulder Arthroplasty (TSA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06109415
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 30 participants
Conditions and interventions
Interventions
- HTX-011 Drug
- Bupivacaine Hydrochloride Drug
- Ibuprofen Drug
- Acetaminophen Drug
- Luer lock applicator Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2021 (Actual)
- Primary completion
- Jul 18, 2022 (Actual)
- Completion
- Jul 29, 2022 (Actual)
- Last update posted
- Oct 31, 2023
2021 – 2022
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | — |
| Center for Orthopaedic Reconstruction and Excellence | Jenks | Oklahoma | 74037 | — |
| First Surgical Hospital | Bellaire | Texas | 77401 | — |
| Legent Orthopedic Hospital | Carrollton | Texas | 75006 | — |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06109415, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 31, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06109415 live on ClinicalTrials.gov.