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NCT04002089 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy

A Phase 1 study of Bunion, sponsored by Pacira Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target
1
Study location

NCT04002089 is a Phase 1 study of Bunion that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 45 participants, below the 171-participant average among 4 other Bunion trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04002089, a Phase 1 study of Bunion, has completed, sponsored by Pacira Pharmaceuticals.

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

Study Summary

This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa). A total of 10 subjects will be enrolled in each of the 4 cohorts.

Conditions Studied

Interventions

  • DRUG Bupivacaine
  • DRUG Exparel Injectable Product

Study Locations (1)

Texas

  • First Surgical Hospital - Bellaire

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2019-07-26
Est. Completion 2019-12-02
Phase Phase 1

Sponsor

Pacira Pharmaceuticals

88 total trials

What the Registry Record Tells You About NCT04002089

The ClinicalTrials.gov registry entry for NCT04002089 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 171-participant average among 4 other Bunion trials with a reported enrollment target (74% lower). The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bunion appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.

NCT04002089 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04002089 about?

NCT04002089 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy". This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa). A total of 10 subjects will be enr...

What is the current status of trial NCT04002089?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-07-26. Estimated completion is 2019-12-02.

What conditions does trial NCT04002089 study?

This clinical trial studies the following conditions: Bunion.

What interventions are being tested in trial NCT04002089?

The interventions under investigation include: Bupivacaine (DRUG), Exparel Injectable Product (DRUG).

Who is sponsoring clinical trial NCT04002089?

This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04002089 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.