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

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetic Neuropathy

In brief

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.

Key facts

Study ID: NCT00573261
Run by: Duke University
People needed: 40
Starts: 2006-03-01
Expected to finish: 2008-05-01
Last updated by the study team: 2014-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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