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

Durect

Status and phase: Completed; Phase 2

Conditions: Chronic, Non Malignant Pain

Treatments: Drug: EN3270

Study type: Interventional

Funder types: Industry

Identifiers

NCT00485225

EN3270-201

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 4 patient groups

Transdermal patch (EN3270) - Titration 1

Experimental group

Treatment:

Drug: EN3270

Transdermal patch (EN3270) - Titration 2

Experimental group

Treatment:

Drug: EN3270

Transdermal patch (EN3270) - Titration 3

Experimental group

Treatment:

Drug: EN3270

Transdermal patch (EN3270) - Titration 4

Experimental group

Treatment:

Drug: EN3270