Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
Overview[ - collapse ][ - ]
| 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 or patients with failed low back syndrome (chronic back pain). |
|---|---|
| Condition | Diabetic Neuropathic Pain Chronic Low Back Pain |
| Intervention | Drug: donepezil Drug: duloxetine Drug: donepezil 2.5 mg and duloxetine 30mg Drug: placebo Drug: gabapentin |
| Phase | N/A |
| Sponsor | Wake Forest School of Medicine |
| Responsible Party | Wake Forest School of Medicine |
| ClinicalTrials.gov Identifier | NCT00619983 |
| First Received | February 8, 2008 |
| Last Updated | May 15, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 8, 2008 |
|---|---|
| Last Updated Date | May 15, 2013 |
| Start Date | February 2008 |
| Estimated Primary Completion Date | May 2013 |
| Current Primary Outcome Measures | Pain intensity measurements will be recorded twice daily, using McGill short form pain questionnaire on the PDA. The Visual Analog Pain Scale (VAS) will serve as the primary outcome measure. [Time Frame: Study completion (16 weeks)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy |
|---|---|
| Official Title | Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy |
| 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 patients with failed low back syndrome (chronic back pain). |
| 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 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: donepezil Group 1: Will receive donepezil 5mg once a day Other Names: Aricept®Drug: duloxetine Group 2: Will receive duloxetine 30 mg twice a day Other Names: Cymbalta®Drug: donepezil 2.5 mg and duloxetine 30mg Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg Other Names:
Group 4: Will receive placebo pills Drug: gabapentin Week 8: all subjects will have open label gabapentin added to their randomized study medication Other Names: neurontin |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 22 |
| Estimated Completion Date | May 2013 |
| Estimated Primary Completion Date | May 2013 |
| Eligibility Criteria | Inclusion Criteria: - Diagnosis of diabetic neuropathy - Age 18-80 - Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study Exclusion Criteria: - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00619983 |
|---|---|
| Other Study ID Numbers | IRB00003943 |
| Has Data Monitoring Committee | No |
| Information Provided By | Wake Forest School of Medicine |
| Study Sponsor | Wake Forest School of Medicine |
| Collaborators | National Institute of Neurological Disorders and Stroke (NINDS) |
| Investigators | Principal Investigator: James C Eisenach, MD Wake Forest School of Medicine |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina, United States, 27157 |
|---|---|
| Cleveland Clinic | Cleveland, Ohio, United States, 44195 |