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Duragesic Therapeutic System

Phase 3

Chronic Pain | Small molecule | Pain |Johnson & Johnson|Last Updated: May 18, 2011

Target and mechanism

ModalitySmall molecule

Also known as Duragesic® (fentanyl) Therapeutic Transdermal System (TTS), Duragesic® (fentanyl) Transdermal Therapeutic System (TTS), Duragesic Therapeutic System

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment252

FDA Designations

No designations recorded

Clinical trial landscape

Duragesic Therapeutic System · 2 trials · 1 indication

Phase 3 2
NCT00271466A 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 TherapyChronic Pain
COMPLETED199 Analytics
NCT00271414A 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 TherapyChronic Pain
COMPLETED53 Analytics
PHASE3COMPLETED
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
Chronic Pain
NCT00271466199
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PHASE3COMPLETED
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
Chronic Pain
NCT0027141453
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Study Endpoints

Primary Endpoints

Incidence and severity of adverse events; Physical examination results and vital signs
Incidence and severity of adverse events; Physical examination results and vital signs; Pharmacokinetics

Secondary Endpoints

Parent's global assessment of pain control on Days 1 and 16; Pain level assessed once in the morning and in the evening; Pain level at the time rescue medication is given and one hour afterwards; Pharmacokinetics
Parent's assessment of pain relief, tolerability and convenience (pre-treatment and after patch changes); Investigator's/parent's global assessments on Day 16 of pain control, adverse events, and convenience; Daily pain levels; Rescue medication usage
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Duragesic® (fentanyl) Therapeutic Transdermal System (TTS)DRUG -
Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)DRUG -
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Eligibility Criteria

Age Range2 Years to 15 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients suffering from chronic pain of a well documented cause that requires continuous administration of opioids * Received opioids continuously for a minimum of 7 days prior to enrollment with a projected need for continuous opioids for at least the length of the primary tr...

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Competitive Landscape -Chronic Pain 49 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY2PHASE3Retatrutide
Boston Scientific CorporationBSX5N/AUndisclosed
Creative Medical Technology Holdings, Inc.CELZ1PHASE1CELZ-201-DDT
Zimmer Biomet Holdings, Inc.ZBH6N/AUndisclosed
Hinge Health, Inc. Class AHNGE2N/AUndisclosed
Abbott LaboratoriesABT2N/AUndisclosed
SI-BONE, Inc.SIBN1 - Undisclosed
Axogen, Inc.AXGN1N/AUndisclosed
United Therapeutics CorporationUTHR1PHASE1Metformin
Precision BioSciences, Inc.DTIL1PHASE1MC-1-50
Galapagos NV Sponsored ADRGLPG1 - Undisclosed
Medtronic PlcMDT1 - Undisclosed
Forte Biosciences Inc.FBRX2N/AUndisclosed
Teleflex IncorporatedTFX1 - Undisclosed
Collegium Pharmaceutical, Inc.COLL1N/AUndisclosed
Sage BionetworksSAGE1 - Undisclosed
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