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NCT00813111 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
A Phase 3 study, sponsored by Pacira Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT00813111: Clinical Trial Phase 3 study, sponsored by Pacira Pharmaceuticals.
NCT00813111 is a Phase 3 study that was terminated before completion, run by Pacira Pharmaceuticals. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00813111, a Phase 3 study, was terminated before completion, sponsored by Pacira Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Primary Outcome
Assessments of postoperative pain included pain intensity at rest (using the NRS at rest \[NRS-R\] and with activity \[using the NRS-A\]) where the prescribed activity was raising both arms. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Interventions
- DRUG Bupivacaine HCl
- DRUG SKY0402
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
Why NCT00813111 stopped before completion
NCT00813111 is an interventional study that assigns participants to a tested intervention. The registered 136 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine HCl is the first listed.
NCT00813111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00813111 about?
NCT00813111 is a clinical study titled "Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation". The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare cost...
What is the current status of trial NCT00813111?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2008-11. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00813111?
The interventions under investigation include: Bupivacaine HCl (DRUG), SKY0402 (DRUG).
Who is sponsoring clinical trial NCT00813111?
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 NCT00813111's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 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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