Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
Public ClinicalTrials.gov record NCT00813111. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-blind Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Bilateral, Cosmetic Sub-muscular Breast Augmentation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00813111
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 136 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2008 (Type not available)
- Primary completion
- Feb 2009 (Actual)
- Completion
- Feb 2009 (Actual)
- Last update posted
- Jan 16, 2014
2008 – 2009
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| West Alabama Research, LLC. | Birmingham | Alabama | 35209 | — |
| West Alabama Research, LLC | Birmingham | Alabama | 35209 | — |
| Horizon Research Group, Inc | Mobile | Alabama | 36608 | — |
| La Jolla Spa MD | La Jolla | California | 90237 | — |
| Associates for Plastic Surgery Medical Group, Inc. | La Jolla | California | 92037 | — |
| Lotus Clinical Research | Pasadena | California | 91105 | — |
| Pacific Plastic Surgery | Santa Barbara | California | 93105 | — |
| Miami Plastic Surgery | Miami | Florida | 33176 | — |
| North Fulton Plastic Surgery | Roswell | Georgia | 30076 | — |
| Waldman and Schantz Plastic Surgery | Lexington | Kentucky | 40508 | — |
| Back Bay Plastic Surgery | Boston | Massachusetts | 02116 | — |
| Personal Enhancement Center | Toms River | New Jersey | 08753 | — |
| The Ohio State University Research Foundation | Columbus | Ohio | 43210 | — |
| Research Concepts, Ltd | Bellaire | Texas | 77402 | — |
| Office of Dr. William P. Adams, Jr., MD | University Park | Texas | 75205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00813111, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 16, 2014 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00813111 live on ClinicalTrials.gov.