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NCT01683071 · ClinicalTrials.gov registry record · Phase 2
Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty
A Phase 2 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 297
- Enrollment target
NCT01683071 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 297 participants.
The verdict
NCT01683071, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 297 participants
- Enrollment target
Study Summary
The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2. Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).
Interventions
- DRUG Placebo
- DRUG EXPAREL 67 mg
- DRUG EXPAREL 133 mg
- DRUG EXPAREL 266 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01683071
The ClinicalTrials.gov registry entry for NCT01683071 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 297 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 4 interventions - of which Placebo is the first listed.
NCT01683071 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01683071 about?
NCT01683071 is a clinical study titled "Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty". The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic...
What is the current status of trial NCT01683071?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 297 participants. The study started on 2012-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01683071?
The interventions under investigation include: Placebo (DRUG), EXPAREL 67 mg (DRUG), EXPAREL 133 mg (DRUG), EXPAREL 266 mg (DRUG).
Who is sponsoring clinical trial NCT01683071?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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