Diabetic Neuropathies
Conditions
Brief summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of gabapentin for the treatment of patients with painful diabetic neuropathy. The quality of life of all treated patients was also assessed.
Interventions
DRUGgabapentin
Gabapentin oral capsules: Week 0: Day 1: 300 mg; Day 2: 600 mg (2 doses of 300 mg); Day 3: 900 mg (3 doses of 300 mg), maintained until the end of the week; After this point, the total daily dose was divided in 3 equal doses. Week 1: Day 1: 1200 mg; Day 2 to 7: 1800 mg Week 2: Day 1: 2100 mg; Day 2 to 7: 2400 mg Week 3: Day 1: 2700 mg; Day 2 to 7: 3600 mg Weeks 4 to 11: 3600 mg
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with stable Diabetes Mellitus 1 or 2 * Clinical diagnosis of distal symmetric polyneuropathy with a minimum duration of 8 weeks * No clinically significant motor deficits * Pain described according to at least one of the following clinical manifestations: burning, cramps or twinges, thermal or mechanical alodinea
Exclusion criteria
* Treatment with any medication that may interfere with the assessment of gabapentin during the study or within 7 days of the adminstration of gabapentin * Specific systemic diseases or other medical conditions that would interfere with the assessment of gabapentin therapeutic response or safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Mean Pain Score | Endpoint |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of responding patients | Endpoint |
| Change from baseline Mean Pain Interference with Sleep Score | Weekly and Endpoint |
| Change from baseline in the 5 sub-scores of the McGill Reduced Pain Questionnaire: the sensory score, the affective score, the total score for pain descriptors, a visual analogue scale, and a scale of Present Pain Intensity | Endpoint |
| Change from baseline Mean Pain Score | Weekly |
| Change from baseline in quality of life | Endpoint |
| Global Change Impression from the Physician's Point of View | Endpoint |
| Global Change Impression from the Patient's Point of View | Endpoint |
Countries
Brazil
Outcome results
None listed