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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: Completed Phase 1 study of Bunion, sponsored by Pacira Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the plasma concentration-versus-time curve (AUC).
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Exparel Injectable Product
Study Locations (1)
Texas
- First Surgical Hospital - Bellaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2019-12-02 |
| Phase | Phase 1 |
What the finished NCT04002089 record still lists
NCT04002089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 171-participant average among 4 other Bunion trials with a reported enrollment target (74% lower).
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 a single indexed study location in 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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