CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
SKY0402 + bupivacaine HCl +1 moredrug
Likely dose
SKY0402 + bupivacaine HCl 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01206608
NCT01206608Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Control Study to Evaluate the Safety and Efficacy of a Single Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Augmentation Mammoplasty

Pacira Pharmaceuticals, Inc·interventional·Posted Sep 22, 2010·Updated Mar 2, 2021

In Brief

A Phase 2 clinical trial evaluating SKY0402 + bupivacaine HCl and Mid-dose SKY0402 + bupivacaine HCl for Postoperative Pain. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2010
Enrollment StartMar 1, 2008
Primary CompletionAug 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.8 years ago

Interventions

SKY0402 + bupivacaine HCldrug

Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

Mid-dose SKY0402 + bupivacaine HCldrug

Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket