A Study on the Efficacy and Safety of Gabapentin in the Treatment of Patients With Painful Diabetic Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: gabapentin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin group<br> | Drug: gabapentin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Mean Pain Score |  | Endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Mean Pain Score |  | Weekly | 
| 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 | 
| Global Change Impression from the Patient's Point of View |  | Endpoint | 
| Change from baseline in quality of life |  | Endpoint | 
| Global Change Impression from the Physician's Point of View |  | Endpoint |