Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain

Study Overview
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Brief Summary
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Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.

Official Title
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An Open-Label, Two-Stage, Phase II Study to Explore the Titration Schedule for Transitioning Opioid-Experienced Patients With Non-Malignant Moderate to Severe Chronic Pain From Current Opioid Therapy to EN3270.

Conditions
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Chronic, Non Malignant Pain

Intervention / Treatment
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* Drug: EN3270


Participation Criteria
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Eligibility Criteria
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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 Are able and willing to follow verbal and written instructions and provide written informed consent Exclusion Criteria: Are pregnant or lactating Have pain secondary to a confirmed or suspected neoplasm Have a history or physical examination finding incompatible with safe participation in the study Have a history of alcohol or drug abuse Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis) Have a history of or currently manifesting a clinically significant psychiatric disorder Have a known history of allergy that negatively impacts respiratory function to a clinically significant level Plan to have an MRI while on the study Have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation Are scheduled for surgery requiring general anesthesia within the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal patch (EN3270) - Titration 1<br> | Drug: EN3270<br>* Transdermal Therapeutic System<br>|
| Experimental: Transdermal patch (EN3270) - Titration 2<br> | Drug: EN3270<br>* Transdermal Therapeutic System<br>|
| Experimental: Transdermal patch (EN3270) - Titration 3<br> | Drug: EN3270<br>* Transdermal Therapeutic System<br>|
| Experimental: Transdermal patch (EN3270) - Titration 4<br> | Drug: EN3270<br>* Transdermal Therapeutic System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and minimum titration period |  | 12 weeks |