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NCT05157841 · ClinicalTrials.gov registry record · Phase 3
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
A Phase 3 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
NCT05157841: Completed Phase 3 study, sponsored by Pacira Pharmaceuticals.
NCT05157841 is a Phase 3 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05157841, a Phase 3 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
Study Summary
The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL. Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.
Primary Outcome
The numeric rating scale pain intensity scores ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 96 hours post-surgery. For each subject, the area under the curve was derived using the trapezoidal rule on the pain scores adjusted for opioid pain medication using the observed and imputed values. Area under the curve started with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 96 hours post-surgery. Pain sco
Interventions
- DRUG Bupivacaine HCl
- DRUG Bupivacaine liposome injectable suspension 266 mg
- DRUG Bupivacaine liposome injectable suspension 133 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2022-08-17 |
| Phase | Phase 3 |
What the finished NCT05157841 record still lists
NCT05157841 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which Bupivacaine HCl is the first listed.
NCT05157841 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05157841 about?
NCT05157841 is a clinical study titled "Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy". The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL. Part B: The purpose is to evaluate the efficacy and safety of ...
What is the current status of trial NCT05157841?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2022-02-15. Estimated completion is 2022-08-17.
What interventions are being tested in trial NCT05157841?
The interventions under investigation include: Bupivacaine HCl (DRUG), Bupivacaine liposome injectable suspension 266 mg (DRUG), Bupivacaine liposome injectable suspension 133 mg (DRUG).
Who is sponsoring clinical trial NCT05157841?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05157841's enrollment target sits among peer trials
185 1417th of 2000 higher than 583 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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