NCT01203644

Evaluation of the Safety, Efficacy, and Pharmacokinetics of SKY0402 in Subjects Undergoing Inguinal Hernia Repair

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

SKY0402 was administered in a dose escalating/de-escalating fashion, with a low starting dose in Cohort 1 that was to be increased or decreased in subsequent cohorts based on safety and analgesic effects. The decision to proceed to the next cohort (i.e., increase or decrease the dose) was made by a Cohort Data Review Committee following a review of the data from the previous cohort. Subjects were randomized to receive either SKY0402 or bupivacaine HCl at a ratio of 1:1 in Cohort 1 and at a ratio of 3:1 in subsequent cohorts. The dose of bupivacaine HCl (100 mg) remained constant for all cohorts.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DRUG	SKY0402	Single dose of SKY0402 administered locally into the surgical wound.
DRUG	Bupivacaine HCl	Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-01-01
• Completion: 2006-12-01
• First posted: 2010-09-16
• Last updated: 2021-01-25
• Results posted: 2012-05-14