Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain (NCT01743976) | Clinical Trial Compass
TerminatedPhase 4
Donepezil Compared to Placebo in Patients With Chronic Neuropathic Pain
Stopped: Failure to recruit subjects
United States5 participantsStarted 2012-12
Plain-language summary
Based on laboratory studies, donepezil will improve pain relief more than placebo in patients with chronic neuropathic pain who are currently taking gabapentin or pregabalin.
Who can participate
Age range18 Years ā 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of diabetic neuropathy or failed back syndrome with neuropathic symptoms
* Age 18-80
* Taking a stable dose of gabapentin or pregabalin
Exclusion Criteria:
* Pregnant women or women of child-bearing potential not willing to practice a reliable form of birth control
* Allergy to donepezil or other piperidine derivatives (including fentanyl, alfentanil, sulfentanil, remifentanyl, demerol, tramadol, loperamide, diphenoxylate, betaprodine, alphaprodine, ethopropazine, anileridine, piminodine, 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine(MPTP),loratadine, fexofenadine
* Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases that, in the opinion of the investigator, would preclude patients from finishing the trial
* Any person with pending litigation
* A history of major psychosis requiring hospitalization within the last three years
* Non-English speaking, illiterate, unable to comprehend consent
* Lack of contact information
* Uncontrolled narrow-angle glaucoma
* Currently being treatment with thioridazine (Mellaril)
* Patients taking opioids will be excluded if they are taking a dosage that exceeds an equivalent of 30 mg of morphine per day
* Patients taking more than one regular (not rescue) medication for pain
* Patients taking donepezil for dementia
* Patients with a baseline pain score less than 2 (0-10 scale) or greater than 8 (0-10) will be excluded
What they're measuring
1
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
Timeframe: baseline
2
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity
Timeframe: Week 8: last week of study drug treatment
3
McGill Short Form Pain Questionnaire (SF MPQ) Visual Analog Scale (VAS) Pain Intensity