Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-Malignant, Chronic Pain - Full Text View

Sponsored by:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00485225

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: Transdermal patch (EN3270)	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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.

Further study details as provided by Endo Pharmaceuticals:

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)

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

Endo Pharmaceuticals

More Information

Responsible Party:	Endo Pharmaceuticals ( Endo Pharmaceuticals )
Study ID Numbers:	EN3270-201
Study First Received:	June 8, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00485225
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009