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NCT03015532 · ClinicalTrials.gov registry record · Phase 2

Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

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

Completed
Registry status
Phase 2
Development phase
285
Enrollment target
20
Study locations

NCT03015532 is a Phase 2 study of Postoperative Pain that has completed, run by Heron Therapeutics. The registered enrollment target is 285 participants, above the 227-participant average among 63 other Postoperative Pain trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT03015532, a Phase 2 study of Postoperative Pain, has completed, sponsored by Heron Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
285 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.

Conditions Studied

Interventions

  • DRUG Saline Placebo
  • DRUG Ropivacaine
  • DRUG HTX-011
  • DRUG Bupivicaine HCl

Study Locations (20)

Texas

  • - Bellaire
  • - Houston
  • - Houston
  • - Houston
  • - Plano

Florida

  • - Miami
  • - Miami
  • - Miami
  • - Tamarac

California

  • - La Jolla
  • - Riverside
  • - San Diego

Ohio

  • - Columbus
  • - Columbus
  • - Dayton

Alabama

  • - Mobile
  • - Sheffield

Arizona

  • - Phoenix
  • - Phoenix

Nevada

  • - Las Vegas

Trial Details

FieldValue
Enrollment Target 285 participants
Start Date 2017-01-13
Est. Completion 2018-05-16
Phase Phase 2

Sponsor

Heron Therapeutics

23 total trials

What the Registry Record Tells You About NCT03015532

The ClinicalTrials.gov registry entry for NCT03015532 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 227-participant average among 63 other Postoperative Pain trials with a reported enrollment target (26% higher). 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 Saline Placebo is the first listed.

NCT03015532 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Texas, Florida, California.

Frequently Asked Questions

What is clinical trial NCT03015532 about?

NCT03015532 is a clinical study titled "Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia". This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgica...

What is the current status of trial NCT03015532?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 285 participants. The study started on 2017-01-13. Estimated completion is 2018-05-16.

What conditions does trial NCT03015532 study?

This clinical trial studies the following conditions: Postoperative Pain.

What interventions are being tested in trial NCT03015532?

The interventions under investigation include: Saline Placebo (DRUG), Ropivacaine (DRUG), HTX-011 (DRUG), Bupivicaine HCl (DRUG).

Who is sponsoring clinical trial NCT03015532?

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

Where is trial NCT03015532 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Nevada. 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.