- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00237341
Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain
November 19, 2013 updated by: PriCara, Unit of Ortho-McNeil, Inc.
Assessing Functionality Changes Associated With Patients Who Were Taking Short Acting Opioids Chronically and Who Initiated Treatment With Duragesic® (Fentanyl Transdermal System) for the Management of Chronic Low Back Pain.
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 medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.
Study Overview
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 very common condition that affects up to a third of people in the US at any time.
The primary objective of the trial is to assess functionality changes over a minimum period of 9 weeks using the Oswestry Disability Index (ODI) - a questionnaire to measure disability - in patients with non-malignant chronic low back pain who are taking short-acting opioids chronically, and who initiate treatment with Duragesic® (transdermal fentanyl).
The patch delivers fentanyl in doses of 25, 50, 75, or 100 micrograms per hour.
The ODI is comprised of 10 sections; each section consists of 6 response alternatives.
The 10 scales assessed by the ODI are Pain Intensity, Personal Care (washing, dressing, etc.), Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, and Traveling.
The secondary objective is to assess changes in health-related quality of life (HRQoL) over the treatment period using the Total Pain Experience (TPE) subscale of the Treatment Outcomes in Pain Survey (TOPS), a questionnaire designed to measure HRQoL changes in patients with chronic pain.
The TOPS contains 112 items that are scored into 16 scales.
These scales include: Pain Symptoms, Lower Body Functional Limitations, Upper Body Functional Limitations, Perceived Family/Social Disability, Objective Family/Social Disability, Objective Work Disability, TPE (a combination of 5 other scales), Life Control, Passive Coping, Solicitous Responses, Work Limitations, Fear Avoidance, Patient Satisfaction with Outcomes, Health Care Satisfaction, Vitality, and Mental Health (the last two from a questionnaire known as the Short Form-36, or SF-36.
Fentanyl transdermal system (skin patch) in a dosage prescribed by the clinical investigator according to the usual standard of care.
Study Type
Interventional
Enrollment (Actual)
358
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial, PriCara, Unit of Ortho-McNeil, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
November 20, 2013
Last Update Submitted That Met QC Criteria
November 19, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- CR002446
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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