Overview

Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wake Forest University
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Treatments:
Donepezil
Duloxetine Hydrochloride
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- Diagnosis of diabetic neuropathy

- Age 18-80

- Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon
entry into the study

Exclusion Criteria:

- Pregnancy

- Allergy to study medications

- Uncontrolled narrow-angle glaucoma

- Currently being treatment with thioridazine (Mellaril)

- Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases

- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization