NCT00744848

Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

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

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Bupivacaine HCl	100 mg Bupivacaine HCl
DRUG	SKY0402	Single administration 300 mg SKY0402 in a 40-mL injection volume

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-09-01
• Last updated: 2013-08-06
• Results posted: 2013-08-06

Locations

20 sites across 1 country: United States