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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 or patients with failed low back syndrome (chronic back pain).
Condition | Intervention |
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Diabetic Neuropathic Pain Chronic Low Back Pain |
Drug: donepezil Drug: duloxetine Drug: donepezil 2.5 mg and duloxetine 30mg Drug: placebo Drug: gabapentin |
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
Drug: gabapentin
Week 8: all subjects will have open label gabapentin added to their randomized study medication
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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
Drug: gabapentin
Week 8: all subjects will have open label gabapentin added to their randomized study medication
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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
Drug: gabapentin
Week 8: all subjects will have open label gabapentin added to their randomized study medication
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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
Drug: gabapentin
Week 8: all subjects will have open label gabapentin added to their randomized study medication
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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 and patients with failed low back syndrome, 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 or their chronic back 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: | August 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00619983 History of Changes |
Health Authority: | United States: Institutional Review Board |
Asymmetric Diabetic Proximal Motor Neuropathy Diabetic Autonomic Neuropathy Diabetic Neuralgia |
Diabetic Neuropathy, Painful Neuralgia, Diabetic Low back pain, chronic |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Gabapentin Psychotropic Drugs Calcium Channel Blockers Pain Cholinergic Agents Duloxetine Signs and Symptoms Dopamine Neuromuscular Diseases Donepezil Analgesics Antidepressive Agents |
Diabetes Complications Nootropic Agents Excitatory Amino Acids Tranquilizing Agents Neuralgia Diabetic Neuropathies Diabetes Mellitus Central Nervous System Depressants Endocrine System Diseases Low Back Pain Cardiovascular Agents Antimanic Agents Serotonin Uptake Inhibitors Back Pain Serotonin |
Dopamine Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Anti-Dyskinesia Agents Gabapentin Physiological Effects of Drugs Calcium Channel Blockers Excitatory Amino Acid Agents Cholinergic Agents Membrane Transport Modulators Neuromuscular Diseases Therapeutic Uses Diabetes Complications Antidepressive Agents |
Tranquilizing Agents Nervous System Diseases Low Back Pain Endocrine System Diseases Cholinesterase Inhibitors Anti-Anxiety Agents Neurotransmitter Uptake Inhibitors Adrenergic Uptake Inhibitors Psychotropic Drugs Antiparkinson Agents Pain Duloxetine Signs and Symptoms Sensory System Agents Donepezil |