Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain
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| ClinicalTrials.gov Identifier: NCT00237341 |
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Recruitment Status :
Completed
First Posted : October 12, 2005
Last Update Posted : November 20, 2013
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Sponsor:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by (Responsible Party):
PriCara, Unit of Ortho-McNeil, Inc.
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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 medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Low Back Pain | Drug: fentanyl | Phase 4 |
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 (Clinical Trial) |
| Actual Enrollment : | 358 participants |
| Official Title: | 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. |
| Study Start Date : | June 2002 |
| Actual Study Completion Date : | January 2004 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237341
Sponsors and Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
| Study Director: | PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial | PriCara, Unit of Ortho-McNeil, Inc. |
Additional Information:
| Responsible Party: | PriCara, Unit of Ortho-McNeil, Inc. |
| ClinicalTrials.gov Identifier: | NCT00237341 |
| Other Study ID Numbers: |
CR002446 |
| First Posted: | October 12, 2005 Key Record Dates |
| Last Update Posted: | November 20, 2013 |
| Last Verified: | November 2013 |
Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:
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chronic low back pain opioid fentanyl |
Additional relevant MeSH terms:
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Back Pain Low Back Pain Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |