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NCT01206608 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
A Phase 2 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01206608 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT01206608, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.
Interventions
- DRUG SKY0402 + bupivacaine HCl
- DRUG Mid-dose SKY0402 + bupivacaine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01206608
The ClinicalTrials.gov registry entry for NCT01206608 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 SKY0402 + bupivacaine HCl is the first listed.
NCT01206608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01206608 about?
NCT01206608 is a clinical study titled "Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty". The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.
What is the current status of trial NCT01206608?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2008-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT01206608?
The interventions under investigation include: SKY0402 + bupivacaine HCl (DRUG), Mid-dose SKY0402 + bupivacaine HCl (DRUG).
Who is sponsoring clinical trial NCT01206608?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
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