Status:
TERMINATED
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Diabetic Neuropathic Pain
Chronic Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 patie...
Detailed Description
Neuropathic pain is a complex and likely heterogeneous disorder, and we recognize that clinically useful agents such as opioids, gabapentin, and antidepressants may be effective precisely because they...
Eligibility Criteria
Inclusion
- Diagnosis of diabetic neuropathy
- Age 18-80
- Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00619983
Start Date
February 1 2008
End Date
May 1 2013
Last Update
September 11 2018
Active Locations (2)
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1
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195