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NCT03295721 · ClinicalTrials.gov registry record · Phase 3
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
A Phase 3 study, sponsored by Heron Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
NCT03295721 is a Phase 3 study that has completed, run by Heron Therapeutics. The registered enrollment target is 412 participants.
The verdict
NCT03295721, a Phase 3 study, has completed, sponsored by Heron Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.
Interventions
- DRUG Saline Placebo
- DRUG HTX-011
- DEVICE Vial access device
- DRUG Bupivacaine HCl
- DEVICE Luer-lock applicator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2018-03-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03295721
The ClinicalTrials.gov registry entry for NCT03295721 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 412 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 Saline Placebo is the first listed.
NCT03295721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03295721 about?
NCT03295721 is a clinical study titled "Bunionectomy Study for Postoperative Analgesia (EPOCH 1)". This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in subjects undergoing bunionectomy.
What is the current status of trial NCT03295721?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2017-10-24. Estimated completion is 2018-03-13.
What interventions are being tested in trial NCT03295721?
The interventions under investigation include: Saline Placebo (DRUG), HTX-011 (DRUG), Vial access device (DEVICE), Bupivacaine HCl (DRUG), Luer-lock applicator (DEVICE).
Who is sponsoring clinical trial NCT03295721?
This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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