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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00485225

Enrollment

Registered

2007-06-12

Start date

2007-06-30

Completion date

2008-07-31

Last updated

2012-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic, Non Malignant Pain

Brief summary

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.

Interventions

DRUGEN3270

Transdermal Therapeutic System

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and minimum titration period	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026