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EN3270

Phase 2

Chronic, Non Malignant Pain | Small molecule | Oncology |DURECT Corporation|Last Updated: Feb 23, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

EN3270 · 1 trial · 1 indication

Phase 2 1
NCT00485225Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic PainChronic, Non Malignant Pain
COMPLETED77 Analytics
PHASE2COMPLETED
Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
Chronic, Non Malignant Pain
NCT0048522577
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Study Endpoints

Primary Endpoints

Safety and minimum titration period
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Transdermal patch (EN3270) - Titration 1EXPERIMENTAL -
Transdermal patch (EN3270) - Titration 2EXPERIMENTAL -
Transdermal patch (EN3270) - Titration 3EXPERIMENTAL -
Transdermal patch (EN3270) - Titration 4EXPERIMENTAL -

Interventions

NameTypeDescription
EN3270DRUGTransdermal Therapeutic System
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Opioid experienced * Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy * On a stable dose of opioid medication for greater than or equal to 14 days * Have an adequate personal support system including a co-habitant ...

Countries:United States
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Frequently asked questions about EN3270

What is EN3270 used for?

EN3270 is an investigational small molecule being developed for the treatment of chronic, non-malignant pain. It is intended for patients with moderate to severe pain of this type. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes EN3270?

EN3270 is being developed by DURECT Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol DRRX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for chronic, non-malignant pain.

What phase is EN3270 in?

EN3270 is in Phase 2 clinical development. A Phase 2 study has been completed, which evaluated the drug in patients with moderate to severe non-malignant chronic pain. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is EN3270 in?

EN3270 has one completed clinical trial, identified as NCT00485225. This was an open-label, controlled, randomized Phase 2 study that enrolled 77 participants in the United States. The trial assessed the safety of EN3270 in patients with moderate to severe non-malignant chronic pain.

Is EN3270 FDA approved?

EN3270 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for chronic, non-malignant pain. The drug is still in clinical development and has not received marketing authorization from the U.S. Food and Drug Administration or any other regulatory agency.