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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR DURAGESIC-25


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505(b)(2) Clinical Trials for Duragesic-25

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 Hea Completed Janssen Research & Development, LLC Phase 1 2015-11-17 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Duragesic-25

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.
NCT00278824 ↗ Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain Terminated ZARS Pharma Inc. Phase 2 2006-01-01 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 2006-10-01 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.
NCT00650117 ↗ Bioequivalence and Wear Study of Mylan Fentanyl Transdermal System 25 µg/h and Mylan Fentanyl Transdermal System Completed Mylan Pharmaceuticals Phase 1 2006-10-01 The objective of this study was to investigate the effect of three different types of occlusive overlays 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. The acute irritation of each type of overlay worn with each fentanyl treatment was also assessed after patch removal.
NCT00650182 ↗ A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant Completed Alza Corporation, DE, USA Phase 2 2003-01-01 The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Duragesic-25

Condition Name

Condition Name for Duragesic-25
Intervention Trials
Healthy 5
Pain 5
Chronic Pain 3
Peer Review, Research 2
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Condition MeSH

Condition MeSH for Duragesic-25
Intervention Trials
Chronic Pain 3
Pain, Postoperative 3
Mucositis 2
Tachycardia 1
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Clinical Trial Locations for Duragesic-25

Trials by Country

Trials by Country for Duragesic-25
Location Trials
United States 29
Thailand 2
Canada 1
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Trials by US State

Trials by US State for Duragesic-25
Location Trials
California 3
Massachusetts 2
Illinois 2
Georgia 2
Florida 2
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Clinical Trial Progress for Duragesic-25

Clinical Trial Phase

Clinical Trial Phase for Duragesic-25
Clinical Trial Phase Trials
Phase 4 7
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Duragesic-25
Clinical Trial Phase Trials
Completed 18
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Duragesic-25

Sponsor Name

Sponsor Name for Duragesic-25
Sponsor Trials
University of Maryland, Baltimore 2
Janssen Research & Development, LLC 2
Khon Kaen University 2
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Sponsor Type

Sponsor Type for Duragesic-25
Sponsor Trials
Other 17
Industry 12
U.S. Fed 2
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Boehringer Ingelheim

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