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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.

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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

FieldValue
Enrollment Target 412 participants
Start Date 2017-10-24
Est. Completion 2018-03-13
Phase Phase 3

Sponsor

Heron Therapeutics

23 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.