NCT00529126

Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy

A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.

Detailed description

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	SKY0402	SKY0402
DRUG	Bupivacaine HCl	Bupivacaine HCl

Timeline

• Start date: 2007-09-01
• Primary completion: 2007-12-01
• Completion: 2008-07-01
• First posted: 2007-09-14
• Last updated: 2021-03-04
• Results posted: 2013-08-06

Locations

7 sites across 2 countries: United States, Georgia