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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier:
NCT00237341
First received: October 7, 2005
Last updated: November 19, 2013
Last verified: November 2013
History of Changes
  Purpose

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 Intervention Phase
Low Back Pain
 Drug: fentanyl
 Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by PriCara, Unit of Ortho-McNeil, Inc.:
Enrollment: 358
Study Start Date: June 2002
Study Completion Date: January 2004
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Additional Information:
Assessing functionality changes associated with patients who were taking short acting opioids chronically and who initiated treatment with Duragesic® for the management of chronic low back pain.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier: NCT00237341     History of Changes
Other Study ID Numbers: CR002446
Study First Received: October 7, 2005
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:
chronic low back pain
opioid
fentanyl

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
 Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015