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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: Completed Phase 3 study, sponsored by Heron Therapeutics.
NCT03295721 is a Phase 3 study that has completed, run by Heron Therapeutics. The registered enrollment target is 412 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720. The prescribed activity for NRS-A is sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight bearing).
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 |
What the finished NCT03295721 record still lists
NCT03295721 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Saline Placebo is the first listed.
NCT03295721 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03295721's enrollment target sits among peer trials
412 906th of 2000 higher than 1,092 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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