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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic, Non Malignant Pain
• Intervention / Treatment: Drug: EN3270

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Opioid experienced
• Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy
• On a stable dose of opioid medication for greater than or equal to 14 days
• Have an adequate personal support system including a co-habitant
• Are able and willing to follow verbal and written instructions and provide written informed consent

Exclusion Criteria:

• Are pregnant or lactating
• Have pain secondary to a confirmed or suspected neoplasm
• Have a history or physical examination finding incompatible with safe participation in the study
• Have a history of alcohol or drug abuse
• Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis)
• Have a history of or currently manifesting a clinically significant psychiatric disorder
• Have a known history of allergy that negatively impacts respiratory function to a clinically significant level
• Plan to have an MRI while on the study
• Have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation
• Are scheduled for surgery requiring general anesthesia within the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdermal patch (EN3270) - Titration 1	Drug: EN3270; Transdermal Therapeutic System
Experimental: Transdermal patch (EN3270) - Titration 2	Drug: EN3270; Transdermal Therapeutic System
Experimental: Transdermal patch (EN3270) - Titration 3	Drug: EN3270; Transdermal Therapeutic System
Experimental: Transdermal patch (EN3270) - Titration 4	Drug: EN3270; Transdermal Therapeutic System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and minimum titration period	12 weeks

Collaborators and Investigators

• Sponsor: Durect

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: June 8, 2007
• First Submitted That Met QC Criteria: June 11, 2007
• First Posted (Estimate): June 12, 2007

Study Record Updates

• Last Update Posted (Estimate): February 23, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: EN3270-201