A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Pfizer
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Outpatients aged 18 years or older

• Meet criteria for diagnosis of diabetic neuropathy

• Average daily pain scores greater than or equal to 4 by Visual Analog Scale

• Ability to give informed consent

• No pregnancy

Exclusion Criteria:

• Patients with clinically significant psychiatric disorders requiring vigorous interventions, i.e., moderate to severe depressive disorder, psychotic disorders, PTSD, obsessive compulsive disorder, panic disorder, substance abuse, or personality disorders, or active suicidal/homicidal ideations, or past history of active suicidal ideation and/or attempts

• Patients on gabapentin which cannot be discontinued, meaning a dose greater than 1200mg. If a patient is on a dose of gabapentin that is less than 1200mg and he or she is willing to stop taking the medication, he or she can participate in the study. These patients must take the last dose of gabapentin the night before starting the study.

• Patients being non-compliant with diabetic control

• Inability to wear the LifeShirt

• Unable to participate or answer questions using a personal digital assistant input device