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Duragesic Therapeutic System

Phase 3

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

Duragesic Therapeutic System target and mechanism

ModalitySmall molecule

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment252

FDA Designations

No designations recorded

Duragesic Therapeutic System clinical trials

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 PainUnlock trial analytics
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 PainUnlock trial analytics

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 78 trials

Frequently asked questions about Duragesic Therapeutic System

What is Duragesic Therapeutic System?

Duragesic Therapeutic System is a fentanyl transdermal patch developed by Johnson & Johnson for chronic pain. It delivers the small molecule fentanyl through the skin for continuous narcotic pain relief therapy. It is studied in patients with chronic pain, including pediatric patients aged 2 years and older who require narcotic pain relief.

What is Duragesic Therapeutic System used for in chronic pain?

Duragesic Therapeutic System is used for the treatment of chronic pain in patients requiring narcotic pain relief therapy. Its clinical program includes children with chronic pain and children with continuous pain who need ongoing opioid analgesia. The patch is designed to provide continuous delivery rather than intermittent dosing.

Who makes Duragesic Therapeutic System?

Duragesic Therapeutic System is developed by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the sponsor of the clinical trials evaluating the fentanyl transdermal patch in chronic pain, including the pediatric studies registered as NCT00271466 and NCT00271414.

What phase is Duragesic Therapeutic System in?

Duragesic Therapeutic System has been evaluated in Phase 3 clinical trials. Two Phase 3 studies are registered, both listed as completed, with no trials currently active. The program enrolled a total of 252 participants across the two completed studies in chronic pain.

What clinical trials is Duragesic Therapeutic System in?

Two completed Phase 3 trials are registered for Duragesic Therapeutic System. NCT00271466 assessed safety, dose conversion, and dose individualization in children with chronic pain requiring narcotic therapy and enrolled 199 participants. NCT00271414 was a 15-day study of safety and clinical utility in children with continuous pain and enrolled 53 participants.

Is Duragesic Therapeutic System the same as Duragesic?

Yes. Duragesic Therapeutic System is also known as Duragesic (fentanyl) Therapeutic Transdermal System (TTS), Duragesic (fentanyl) Transdermal Therapeutic System (TTS), and Duragesic Therapeutic System. These names refer to the same fentanyl transdermal patch developed by Johnson & Johnson for chronic pain.