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

Primary Purpose

Chronic, Non Malignant Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

EN3270

About this trial

This is an interventional treatment trial for Chronic, Non Malignant Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Comprehensive Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Transdermal patch (EN3270) - Titration 1

Transdermal patch (EN3270) - Titration 2

Transdermal patch (EN3270) - Titration 3

Transdermal patch (EN3270) - Titration 4

Arm Description

Outcomes

Primary Outcome Measures

Safety and minimum titration period

Secondary Outcome Measures

Full Information

NCT ID

NCT00485225

First Posted

June 8, 2007

Last Updated

February 21, 2012

Sponsor

Durect

1. Study Identification

Unique Protocol Identification Number

NCT00485225

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Durect

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic, Non Malignant Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transdermal patch (EN3270) - Titration 1

Arm Type

Experimental

Arm Title

Transdermal patch (EN3270) - Titration 2

Arm Type

Experimental

Arm Title

Transdermal patch (EN3270) - Titration 3

Arm Type

Experimental

Arm Title

Transdermal patch (EN3270) - Titration 4

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

EN3270

Intervention Description

Transdermal Therapeutic System

Primary Outcome Measure Information:

Title

Safety and minimum titration period

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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