A Study to Evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

• Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes

• Stable glycemic control for at least 6 months prior to screening visit

• Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit

Exclusion Criteria:

• Primary pain associated with PDPN in the ankles or above

• Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN

• Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain

• Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.

• Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives