At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 76 enrolled

Drug / intervention

SKY0402 +1 moredrug

Likely dose

Bupivacaine HCl 100 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/NCT01203644

NCT01203644Phase 2Completed

Compare CT.gov

A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained Release Encapsulated Bupivacaine (SKY0402) in the Management of Postoperative Pain in Subjects Undergoing Inguinal Hernia Repair

Pacira Pharmaceuticals, Inc·interventional·Posted Sep 16, 2010·Updated Jan 25, 2021

In Brief

A Phase 2 clinical trial evaluating SKY0402 and Bupivacaine HCl for Inguinal Hernia. Completed, enrolled 76 participants.

Detailed Summary

The primary objective of this study was to determine the appropriate dose of SKY0402 for the management of postoperative pain following inguinal hernia repair. This study evaluated the safety, efficacy, and pharmacokinetics of SKY0402 compared with a 100 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing inguinal hernia repair. Study drug was administered by surgical wound infiltration at the end of the hernia repair procedure.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInguinal Hernia

Countries--

Collaborators--

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2004

Primary CompletionJan 2006

Study CompletionDec 2006

First PostedSep 2010

TodayJul 2026

First PostedSep 16, 2010

Enrollment StartDec 1, 2004

Primary CompletionJan 1, 2006

Study CompletionDec 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 15.8 years ago

Interventions

SKY0402drug

Single dose of SKY0402 administered locally into the surgical wound.

Bupivacaine HCldrug

Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.