NCT00485225

Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain

An Open-Label, Two-Stage, Phase II Study to Explore the Titration Schedule for Transitioning Opioid-Experienced Patients With Non-Malignant Moderate to Severe Chronic Pain From Current Opioid Therapy to EN3270.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Durect · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.

Conditions

• Chronic, Non Malignant Pain

Interventions

Type	Name	Description
DRUG	EN3270	Transdermal Therapeutic System

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2007-06-12
• Last updated: 2012-02-23

Locations

1 site across 1 country: United States