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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: Completed Phase 2 study, sponsored by Pacira Pharmaceuticals.
NCT01206608 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.
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 |
What the finished NCT01206608 record still lists
NCT01206608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which SKY0402 + bupivacaine HCl is the first listed.
NCT01206608 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01206608's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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