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