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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
History of Changes
  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:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

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
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 May 23, 2013