Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain
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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. |
ClinicalTrials.gov Identifier: NCT00237341 |
Recruitment Status :
Completed
First Posted : October 12, 2005
Last Update Posted : November 20, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Back Pain | Drug: fentanyl | Phase 4 |
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 |
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

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
Study Director: | PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial | PriCara, Unit of Ortho-McNeil, Inc. |
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 |
chronic low back pain opioid fentanyl |
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 |