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NCT02985762 · ClinicalTrials.gov registry record · Phase 1
PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery
A Phase 1 study of Pain Management and Spinal Fusion, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 3
- Study locations
NCT02985762: Completed Phase 1 study of Pain Management and Spinal Fusion, sponsored by Pacira Pharmaceuticals.
NCT02985762 is a Phase 1 study of Pain Management and Spinal Fusion that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 15 participants, below the 154-participant average among 31 other Pain Management trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02985762, a Phase 1 study of Pain Management and Spinal Fusion, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery. The secondary objectives of this study are to assess the safety, tolerability, and efficacy of EXPAREL in this surgical model.
Conditions Studied
Interventions
- DRUG EXPAREL
Study Locations (3)
Florida
- University of Miami - Miami
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-09 |
| Phase | Phase 1 |
What the finished NCT02985762 record still lists
NCT02985762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 154-participant average among 31 other Pain Management trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Pain Management appearing as the primary indexed condition, and to 1 intervention - of which EXPAREL is the first listed.
NCT02985762 reports a single indexed study location in Florida, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02985762 about?
NCT02985762 is a clinical study titled "PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery". The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery. The secondary objectives of this study are to assess the safety, tolerability, and e...
What is the current status of trial NCT02985762?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-12. Estimated completion is 2017-09.
What conditions does trial NCT02985762 study?
This clinical trial studies the following conditions: Pain Management, Spinal Fusion.
What interventions are being tested in trial NCT02985762?
The interventions under investigation include: EXPAREL (DRUG).
Who is sponsoring clinical trial NCT02985762?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02985762 being conducted?
This trial has 3 study locations across Florida, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02985762's enrollment target sits among peer trials
15 25th of 31 higher than 3 of 31 other Pain Management trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain Management trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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