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NCT03015961 · ClinicalTrials.gov registry record · Phase 4
Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
A Phase 4 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT03015961 is a Phase 4 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 38 participants.
The verdict
NCT03015961, a Phase 4 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study Summary
Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery. Secondary Objectives: The secondary objectives of this study are to compare additional efficacy, safety, and health economic outcomes following LIA with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery.
Interventions
- DRUG Bupivacaine HCl
- DRUG EXPAREL and bupivacaine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03015961
The ClinicalTrials.gov registry entry for NCT03015961 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 38 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 0 conditions, and to 2 interventions - of which Bupivacaine HCl is the first listed.
NCT03015961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03015961 about?
NCT03015961 is a clinical study titled "Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery". Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult subjects undergoing open lumbar posterior spinal fusion surgery. Secondary O...
What is the current status of trial NCT03015961?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2017-02-21. Estimated completion is 2017-10-30.
What interventions are being tested in trial NCT03015961?
The interventions under investigation include: Bupivacaine HCl (DRUG), EXPAREL and bupivacaine HCl (DRUG).
Who is sponsoring clinical trial NCT03015961?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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