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Sponsors and Collaborators: |
Wake Forest University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00619983 |
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 |
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Diabetic Neuropathic Pain |
Drug: donepezil Drug: duloxetine Drug: donepezil 2.5 mg and duloxetine 30mg Drug: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy |
Estimated Enrollment: | 60 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Donepezil 5 mg once per day for 12 weeks. Gabapentin will be added to all groups at week 9.
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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.
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Wake Forest University Health Sciences ( James C. Eisenach, M.D. ) |
Study ID Numbers: | IRB00003943, NS59574 |
Study First Received: | February 8, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00619983 |
Health Authority: | United States: Institutional Review Board |
Asymmetric Diabetic Proximal Motor Neuropathy Diabetic Autonomic Neuropathy Diabetic Neuralgia Diabetic Neuropathy, Painful Neuralgia, Diabetic |
Diabetic Neuropathies Neuralgia Gabapentin Diabetes Mellitus Endocrine System Diseases Pain Serotonin Duloxetine |
Motor neuropathy Dopamine Neuromuscular Diseases Peripheral Nervous System Diseases Donepezil Endocrinopathy Diabetes Complications |
Dopamine Uptake Inhibitors Nootropic Agents Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs |
Enzyme Inhibitors Cholinergic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Cholinesterase Inhibitors Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |