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CLINICAL TRIALS PROFILE FOR DURAGESIC-100

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Clinical Trials for Duragesic-100

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.

Clinical Trial Conditions for Duragesic-100

Condition Name

Condition Name for Duragesic-100
Intervention	Trials
Healthy	5
Chronic Pain	3
Pain	3
Peer Review, Research	2

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Condition MeSH

Condition MeSH for Duragesic-100
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Breakthrough Pain	1
Low Back Pain	1

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Clinical Trial Locations for Duragesic-100

Trials by Country

Trials by Country for Duragesic-100
Location	Trials
United States	23
Thailand	2
Canada	1

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Trials by US State

Trials by US State for Duragesic-100
Location	Trials
California	3
Georgia	2
Florida	2
Maryland	2
West Virginia	2

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Clinical Trial Progress for Duragesic-100

Clinical Trial Phase

Clinical Trial Phase for Duragesic-100
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	2
Phase 2	2

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Clinical Trial Status

Clinical Trial Status for Duragesic-100
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

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Clinical Trial Sponsors for Duragesic-100

Sponsor Name

Sponsor Name for Duragesic-100
Sponsor	Trials
Khon Kaen University	2
Janssen Research & Development, LLC	2
Alza Corporation, DE, USA	2

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Sponsor Type

Sponsor Type for Duragesic-100
Sponsor	Trials
Industry	12
Other	8
U.S. Fed	2

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