Status:
COMPLETED
Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain
Lead Sponsor:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain ...
Detailed Description
Chronic pain (pain that lasts for more than 3 months) can limit physical functioning and negatively affect a person socially and emotionally. Chronic low back pain (that is not caused by cancer) is a ...
Eligibility Criteria
Inclusion
- Chronic low back pain (not related to cancer) for at least 3 months
- current use of short-acting opioid (narcotic pain medication) for at least 4 weeks
- initiating fentanyl transdermal patch.
Exclusion
- Confusion or reduced level of consciousness
- skin disease
- malignancies (cancer)
- currently hospitalized
- treated with a long-acting opioid within the last 2 months
- pregnant or breast-feeding
- abusing drugs or alcohol
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00237341
Start Date
June 1 2002
End Date
January 1 2004
Last Update
November 20 2013
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