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NCT03718039 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Bunionectomy HTX-011 Administration Study

A Phase 2 study of Postoperative Pain, sponsored by Heron Therapeutics.

Completed
Registry status
Phase 2
Development phase
78
Enrollment target
1
Study location

NCT03718039 is a Phase 2 study of Postoperative Pain that has completed, run by Heron Therapeutics. The registered enrollment target is 78 participants, below the 230-participant average among 63 other Postoperative Pain trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03718039, a Phase 2 study of Postoperative Pain, has completed, sponsored by Heron Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
78 participants
Enrollment target
1
Study location

Study Summary

This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral simple bunionectomy.

Conditions Studied

Interventions

  • DRUG HTX-011
  • DEVICE Luer Lock applicator
  • DEVICE Vial access device
  • DRUG aprepitant

Study Locations (1)

Texas

  • Endeavor Clinical Trials, LLC - San Antonio

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2018-10-24
Est. Completion 2019-03-11
Phase Phase 2

Sponsor

Heron Therapeutics

23 total trials

What the Registry Record Tells You About NCT03718039

The ClinicalTrials.gov registry entry for NCT03718039 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 63 other Postoperative Pain trials with a reported enrollment target (66% lower). The listed sponsor is Heron Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 4 interventions - of which HTX-011 is the first listed.

NCT03718039 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03718039 about?

NCT03718039 is a clinical study titled "Phase 2 Bunionectomy HTX-011 Administration Study". This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with other medications to enhance analgesia in subjects undergoing unilateral si...

What is the current status of trial NCT03718039?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2018-10-24. Estimated completion is 2019-03-11.

What conditions does trial NCT03718039 study?

This clinical trial studies the following conditions: Postoperative Pain.

What interventions are being tested in trial NCT03718039?

The interventions under investigation include: HTX-011 (DRUG), Luer Lock applicator (DEVICE), Vial access device (DEVICE), aprepitant (DRUG).

Who is sponsoring clinical trial NCT03718039?

This trial is sponsored by Heron Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03718039 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.