Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
NCT ID: NCT00485225
Last Updated: 2012-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2007-06-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transdermal patch (EN3270) - Titration 1
EN3270
Transdermal Therapeutic System
Transdermal patch (EN3270) - Titration 2
EN3270
Transdermal Therapeutic System
Transdermal patch (EN3270) - Titration 3
EN3270
Transdermal Therapeutic System
Transdermal patch (EN3270) - Titration 4
EN3270
Transdermal Therapeutic System
Interventions
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EN3270
Transdermal Therapeutic System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Durect
INDUSTRY
Responsible Party
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Locations
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Comprehensive Clinical Research
Berlin, New Jersey, United States
Countries
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Other Identifiers
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EN3270-201
Identifier Type: -
Identifier Source: org_study_id
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