MedTrace Logo

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

NCT00806806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2010-09-06

No results posted yet for this study

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.

Conditions

  • Postoperative Pain Management

Interventions

DRUG

SKY0402

Local administration of SKY0402 followed by noxious stimulus

DRUG

Placebo

Local administration of Placebo followed by noxious stimuli

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Marius Ardeleanu, MD · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806806 on ClinicalTrials.gov