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CLINICAL TRIALS PROFILE FOR DURAGESIC-12
Clinical Trials for Duragesic-12
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00237341 | Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain | Completed | PriCara, Unit of Ortho-McNeil, Inc. | Phase 4 | 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. |
| NCT00271414 | A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy | Completed | Janssen Pharmaceutica N.V., Belgium | Phase 3 | The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed. |
| NCT00271466 | A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 3 | The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy. Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the subject's current narcotic pain relief therapy, and to the parameters for increasing the Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed. |
| NCT00278824 | Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain | Terminated | ZARS Pharma Inc. | Phase 2 | A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm. |
| NCT00648414 | Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr | Terminated | Mylan Pharmaceuticals | Phase 1 | The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation. |
| Trial ID | Title | Status | Sponsor | Phase | Summary |
Clinical Trial Conditions for Duragesic-12
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Clinical Trial Sponsors for Duragesic-12
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