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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Durect
ClinicalTrials.gov Identifier:
NCT00485225
First received: June 8, 2007
Last updated: February 21, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Chronic, Non Malignant Pain
Drug: EN3270
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Durect:

Primary Outcome Measures:
  • Safety and minimum titration period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485225

Locations
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Sponsors and Collaborators
Durect
  More Information

No publications provided

Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT00485225     History of Changes
Other Study ID Numbers: EN3270-201
Study First Received: June 8, 2007
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014