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| Sponsors and Collaborators: |
Wake Forest University National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00619983 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetic Neuropathic Pain |
Drug: donepezil Drug: duloxetine Drug: donepezil 2.5 mg and duloxetine 30mg Drug: placebo |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Donepezil 5 mg once per day for 12 weeks. Gabapentin will be added to all groups at week 9.
|
Drug: donepezil
Group 1: Will receive donepezil 5mg once a day
|
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2: Active Comparator
Group 2: Will receive duloxetine 30 mg twice a day for 12 weeks. Gabapentin will be added to all groups at week 9.
|
Drug: duloxetine
Group 2: Will receive duloxetine 30 mg twice a day
|
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3: Active Comparator
Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg for 12 weeks. Gabapentin will be added to all groups at week 9.
|
Drug: donepezil 2.5 mg and duloxetine 30mg
Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg
|
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4: Placebo Comparator
Group 4:Will receive placebo pills. Gabapentin will be added to all groups at week 9.
|
Drug: placebo
Group 4: Will receive placebo pills
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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 have multiple mechanisms of action at multiple sites. This study, however, will not only provide important mechanistic information regarding one cascade which can be manipulated for analgesia, but will also provide much needed systematic and practical guidance for multi-drug therapy in patients with neuropathic pain.
This study in patients with diabetic neuropathic pain, culminate in a quantitative description of interactions between activators of descending noradrenergic activity, norepinephrine transporter inhibitors, and cholinesterase inhibitors to exploit the plasticity of analgesia in chronic pain states. We will focus on practical applications, using clinically approved drugs, including gabapentin (Neurontin®) to activate noradrenergic activity, duloxetine (Cymbalta®) to inhibit the norepinephrine transporter, and donepezil (Aricept®), approved for the treatment of Alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase.
After the baseline measurements and physical examination patients will be trained to use a Personal Digital Assistant (PDA) to answer questions about their diabetic neuropathic pain. Upon successful completion of these tasks the patients will be randomized to receive one of the drug choices or placebo (inactive pill).
The study will last for a total of 16 weeks and includes 5 visits to the research center with each visit lasting approximately 2 hours.
Eligibility
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Regina Curry, RN, CCRC | 336-716-4294 | recurry@wfubmc.edu |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Regina Curry, RN, CCRC 336-716-4294 recurry@wfubmc.edu | |
| Principal Investigator: James C. Eisenach, MD | |
| Sub-Investigator: James C. Crews, MD | |
| Sub-Investigator: James B. Caress, MD | |
| Principal Investigator: | James C Eisenach, MD | Wake Forest University |
More Information
