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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durect

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