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Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237341
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : November 20, 2013
Information provided by (Responsible Party):
PriCara, Unit of Ortho-McNeil, Inc.

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00237341

Sponsors and Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
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Study Director: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial PriCara, Unit of Ortho-McNeil, Inc.
Additional Information:
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Responsible Party: PriCara, Unit of Ortho-McNeil, Inc. 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.:
chronic low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General