NCT00806806

Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers

A Phase 1 Randomized, Single-blind, Sequential Cohort, Crossover Study to Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and extended pain relief that could greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize episodes of breakthrough pain.

Detailed description

Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the time to onset will be recorded.

Conditions

• Postoperative Pain Management

Interventions

Type	Name	Description
DRUG	SKY0402	Local administration of SKY0402 followed by noxious stimulus
DRUG	Placebo	Local administration of Placebo followed by noxious stimuli

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-12-11
• Last updated: 2010-09-06

Locations

1 site across 1 country: United States