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NCT04398329 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation Study of HTX-034 Following Bunionectomy
A Phase 1 study, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT04398329 is a Phase 1 study that has completed, run by Heron Therapeutics. The registered enrollment target is 78 participants.
The verdict
NCT04398329, a Phase 1 study, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.
Interventions
- DRUG Bupivacaine HCl
- DRUG HTX-034 low dose
- DRUG HTX-034 high dose
- DEVICE Luer lock applicator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2020-05-08 |
| Est. Completion | 2021-07-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04398329
The ClinicalTrials.gov registry entry for NCT04398329 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 78 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 4 interventions - of which Bupivacaine HCl is the first listed.
NCT04398329 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04398329 about?
NCT04398329 is a clinical study titled "Dose-Escalation Study of HTX-034 Following Bunionectomy". This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HC...
What is the current status of trial NCT04398329?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2020-05-08. Estimated completion is 2021-07-15.
What interventions are being tested in trial NCT04398329?
The interventions under investigation include: Bupivacaine HCl (DRUG), HTX-034 low dose (DRUG), HTX-034 high dose (DRUG), Luer lock applicator (DEVICE).
Who is sponsoring clinical trial NCT04398329?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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