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NCT03485014 · ClinicalTrials.gov registry record · Phase 1
Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
A Phase 1 study of Postoperative Pain Management, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03485014: Completed Phase 1 study of Postoperative Pain Management, sponsored by Pacira Pharmaceuticals.
NCT03485014 is a Phase 1 study of Postoperative Pain Management that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 15 participants, below the 138-participant average among 7 other Postoperative Pain Management trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03485014, a Phase 1 study of Postoperative Pain Management, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery. Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery.
Primary Outcome
Area under the concentration curve for EXPAREL
Conditions Studied
Interventions
- DRUG Exparel
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2019-02-12 |
| Phase | Phase 1 |
What the finished NCT03485014 record still lists
NCT03485014 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 138-participant average among 7 other Postoperative Pain Management trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Postoperative Pain Management appearing as the primary indexed condition, and to 1 intervention - of which Exparel is the first listed.
NCT03485014 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03485014 about?
NCT03485014 is a clinical study titled "Study in Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL". Primary objective: The primary objective of this study is to evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects 12 to less than 17 years of age undergoing spinal surgery. Secondary objective: The secondary objective of this study is to evaluate the safety of EXPAREL in pediatric su...
What is the current status of trial NCT03485014?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-04-10. Estimated completion is 2019-02-12.
What conditions does trial NCT03485014 study?
This clinical trial studies the following conditions: Postoperative Pain Management.
What interventions are being tested in trial NCT03485014?
The interventions under investigation include: Exparel (DRUG).
Who is sponsoring clinical trial NCT03485014?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03485014 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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