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CLINICAL TRIALS PROFILE FOR DURAGESIC-100

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505(b)(2) Clinical Trials for Duragesic-100

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02608320	A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Heal	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-01	The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
New Formulation	NCT02617758	Bioequivalence Study of Fentanyl Transdermal System (JNJ-35685-AAA-G021) Compared With DURAGESIC Fentanyl Transdermal Patch in Healthy Participants	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-01	The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.

All Clinical Trials for Duragesic-100

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00237341	Duragesic® (Fentanyl Transdermal System) Functionality Trial in Chronic Low Back Pain	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2002-06-01	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	1999-03-01	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	2000-02-01	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.

Clinical Trial Conditions for Duragesic-100

Condition Name

Condition Name for Duragesic-100
Intervention	Trials
Healthy	5
Chronic Pain	3
Pain	3

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Condition MeSH

Condition MeSH for Duragesic-100
Intervention	Trials
Chronic Pain	3
Pain, Postoperative	3
Breakthrough 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
West Virginia	2
Georgia	2
Florida	2
Maryland	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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