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.
1 other identifier
interventional
77
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 8, 2007
CompletedFirst Posted
Study publicly available on registry
June 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFebruary 23, 2012
December 1, 2011
10 months
June 8, 2007
February 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and minimum titration period
12 weeks
Study Arms (4)
Transdermal patch (EN3270) - Titration 1
EXPERIMENTALTransdermal patch (EN3270) - Titration 2
EXPERIMENTALTransdermal patch (EN3270) - Titration 3
EXPERIMENTALTransdermal patch (EN3270) - Titration 4
EXPERIMENTALInterventions
Transdermal Therapeutic System
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Durectlead
Study Sites (1)
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2007
First Posted
June 12, 2007
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
July 1, 2008
Last Updated
February 23, 2012
Record last verified: 2011-12