NCT00619983

Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathic Pain
• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	donepezil	Group 1: Will receive donepezil 5mg once a day
DRUG	duloxetine	Group 2: Will receive duloxetine 30 mg twice a day
DRUG	donepezil 2.5 mg and duloxetine 30mg	Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2008-02-21
• Last updated: 2018-09-11
• Results posted: 2017-08-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study