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Duragesic

Phase 1

Pain | Small molecule | Pain |Novartis AG|Last Updated: Mar 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Duragesic · 1 trial · 1 indication

Phase 1 1
NCT00857753Relative Bioavailability of a Fentanyl PatchPain
COMPLETED40 Analytics
PHASE1COMPLETED
Relative Bioavailability of a Fentanyl Patch
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence according to US FDA guidelines
3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFentanyl patch 25 ug/hr Sandoz
2ACTIVE_COMPARATORDuragesic Patch 25 ug/hr

Interventions

NameTypeDescription
Fentanyl patch 25 ug/nr SandozDRUG -
DuragesicDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening. Exclusion Criteria: * Negative test for HIV and hepatitis B and C * No history of drug or alcohol treatment * No allergies to opiates

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Frequently asked questions about Duragesic

What is Duragesic used for?

Duragesic is used for pain. It is a small molecule drug being developed by Novartis AG. The drug is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for use. One clinical trial has been completed for this indication.

Who makes Duragesic?

Duragesic is developed by Novartis AG, which trades under the ticker symbol NVS. The drug is a small molecule being studied for the treatment of pain. It is currently in Phase 1 clinical development, with one completed trial.

What phase is Duragesic in?

Duragesic is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for pain. One Phase 1 trial has been completed, involving 40 participants. The drug is not currently in active clinical trials.

What clinical trials is Duragesic in?

Duragesic has one completed clinical trial, NCT00857753, titled "Relative Bioavailability of a Fentanyl Patch." This Phase 1 study enrolled 40 participants and was active-controlled, though not double-blinded. The trial involved healthy volunteers aged 18 years and older.

Is Duragesic the same as fentanyl?

Duragesic is a fentanyl patch, as indicated by the clinical trial title "Relative Bioavailability of a Fentanyl Patch." The drug is a small molecule developed by Novartis AG for pain. It is currently in Phase 1 development, with one completed trial.