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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: Completed Phase 1 study, sponsored by Heron Therapeutics.
NCT04398329 is a Phase 1 study that has completed, run by Heron Therapeutics. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
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 |
What the finished NCT04398329 record still lists
NCT04398329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 4 interventions - of which Bupivacaine HCl is the first listed.
NCT04398329 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04398329's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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