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Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation

NCT00813111 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2014-01-16

Study results available
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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.

Conditions

Interventions

DRUG

SKY0402

600mg SKY0402 instilled into breast pocket during surgery

DRUG

Bupivacaine HCl

200mg Bupivacaine HCl instilled into breast pocket during surgery

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Kay Warnott, RN · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813111 on ClinicalTrials.gov