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NCT04293809 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation
A Phase 1 study of Breast Augmentation, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04293809 is a Phase 1 study of Breast Augmentation that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04293809, a Phase 1 study of Breast Augmentation, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
Conditions Studied
Interventions
- DRUG Bupivacaine Hydrochloride
- DRUG Exparel Injectable Product
Study Locations (1)
Texas
- HD Research - Bellaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2020-01-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04293809
The ClinicalTrials.gov registry entry for NCT04293809 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Augmentation appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine Hydrochloride is the first listed.
NCT04293809 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04293809 about?
NCT04293809 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of EXPAREL Administered as a Pectoral Plane Block in Women Undergoing Breast Augmentation". This is a pilot, open label, single center study in 30 women undergoing breast augmentation. The study will assess and collect information on pharmacokinetics and safety of EXPAREL administered as a pectoral plane block. A total of 15 subjects will be enrolled in each of the 2 cohorts.
What is the current status of trial NCT04293809?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-12-19. Estimated completion is 2020-01-29.
What conditions does trial NCT04293809 study?
This clinical trial studies the following conditions: Breast Augmentation.
What interventions are being tested in trial NCT04293809?
The interventions under investigation include: Bupivacaine Hydrochloride (DRUG), Exparel Injectable Product (DRUG).
Who is sponsoring clinical trial NCT04293809?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04293809 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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