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NCT06109415 · ClinicalTrials.gov registry record · Phase 4
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.
A Phase 4 study, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT06109415 is a Phase 4 study that has completed, run by Heron Therapeutics. The registered enrollment target is 30 participants.
The verdict
NCT06109415, a Phase 4 study, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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).
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Bupivacaine Hydrochloride
- DRUG HTX-011
- DEVICE Luer lock applicator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2022-07-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06109415
The ClinicalTrials.gov registry entry for NCT06109415 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Heron Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT06109415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06109415 about?
NCT06109415 is a clinical study titled "A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.". 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).
What is the current status of trial NCT06109415?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2021-10-20. Estimated completion is 2022-07-29.
What interventions are being tested in trial NCT06109415?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG), Bupivacaine Hydrochloride (DRUG), HTX-011 (DRUG), Luer lock applicator (DEVICE).
Who is sponsoring clinical trial NCT06109415?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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