Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
TerminatedPhase 4NCT00619983
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy
- Conditions
- Diabetic Neuropathic Pain
- Chronic Low Back Pain
- Interventions
- Drug: donepezil
- Drug: duloxetine
- Drug: donepezil 2.5 mg and duloxetine 30mg
- Drug: placebo
- Drug: gabapentin
- Sponsor
- Wake Forest University
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Organization
- Wake Forest University Health Sciences
- Start date
- 2008-02
- Primary completion
- 2013-05
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00619983