Neuropathic pain Nervous System Diseases Neuropathic pain
Conditions
Interventions
Oral administration of:
1. Gabapentin
2. Nortriptyline
3. A gabapentin-nortriptyline combination
The end date of this trial is still being discussed, the anticipated end date entered above is an arbi
Sponsors
Canadian Institutes of Health Research (CIHR) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetic patients of either sex 2. 18 to 89 years of age 3. Distal, symmetric, sensory polyneuropathy
Exclusion criteria
Exclusion criteria: 1. Neuropathy attributable to an etiology other than diabetes (e.g. hypothyroidism, vitamin B12 deficiency, connective tissue disease, amyloidosis and toxic exposure) 2. Presence of a painful condition as severe as, but distinct from, their diabetic neuropathy pain 3. Pregnancy or lactation 4. End-stage kidney or liver disease 5. Moderate to severe heart disease (Myocardial Infarction [MI] within preceding year, unstable angina, cardiac conduction defect or congestive heart failure) 6. Cardiovascular autonomic neuropathy 7. Postural hypotension more than 20 mmHg on initial assessment 8. Baseline mild to severe sedation or ataxia due to required concomitant drugs, or any other cause 9. Males with urinary symptoms attributable to benign prostatic hypertrophy 10. Presence of a seizure disorder 11. Angle-closure glaucoma 12. Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist 13. Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g. carbamazepine, oxcarbazepine) 14. Hypersensitivity to any of the study medications 15. History of significant abuse of illicit drugs, prescription drugs or alcohol 16. Lack of a primary physician 17. Patients who live alone and cannot assure daily contact with a friend, family member or caregiver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of this study will be the mean daily pain intensity from the last seven days, at maximal tolerated dose, of each treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will include frequency and severity of treatment-emergent adverse effects, global pain relief ratings, the short form McGill Pain Questionnaire, a pain interference questionnaire (Brief Pain Inventory), consumption of rescue medication (number of acetaminophen 325 mg tablets), a blinding questionnaire, two mood questionnaires (Beck Depression Inventory and Profile of Mood States) and a quality of life survey (SF-36). | — |
Countries
Canada
Outcome results
None listed