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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Diabetic Neuropathic Pain, Chronic Low Back Pain

In brief

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).

Key facts

Study ID

NCT00619983

Run by

Wake Forest University

People needed

22

Starts

2008-02-01

Expected to finish

2013-05-01

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetic neuropathy
• Age 18-80
• Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study

You may not qualify if…

• 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

Where it is running

• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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