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

Phase 2

Completed

• Conditions: Chronic, Non Malignant Pain
• Interventions: Drug: EN3270

• Registration Number: NCT00485225
• Lead Sponsor: Durect

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-11
• Study First Posted: 2007-06-12
• Primary Completion: 2008-04
• Study Completion: 2008-07
• Status Verified: 2011-12
• Disposition First Submitted: 2012-02-21
• Disposition First Submitted QC: 2012-02-21
• Last Update Submitted: 2012-02-21
• Disposition First Posted: 2012-02-23
• Last Update Posted: 2012-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transdermal patch (EN3270) - Titration 2	EN3270	-
Transdermal patch (EN3270) - Titration 1	EN3270	-
Transdermal patch (EN3270) - Titration 3	EN3270	-
Transdermal patch (EN3270) - Titration 4	EN3270	-

Primary Outcome Measures

Name	Time	Method
Safety and minimum titration period	12 weeks

Trial Locations

Locations (1)

Comprehensive Clinical Research; 🇺🇸 Berlin, New Jersey, United States