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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Neuropathies

Interventions

gabapentinDRUG

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

Eligibility

Sex: ALLMin age: 51 Years

Medical Language ↔ Plain English

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

Locations (10)

Pfizer Investigational Site

Fortaleza, Ceará, Brazil

Pfizer Investigational Site

Taguatinga, Federal District, Brazil

Pfizer Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Outcomes

Primary Outcomes

Change from baseline Mean Pain Score

Time frame: Endpoint

Secondary Outcomes

Change from baseline Mean Pain Score

Time frame: Weekly

Proportion of responding patients

Time frame: Endpoint

Change from baseline Mean Pain Interference with Sleep Score

Time frame: 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

Time frame: Endpoint

Global Change Impression from the Patient's Point of View

Time frame: Endpoint

Change from baseline in quality of life

Time frame: Endpoint

Global Change Impression from the Physician's Point of View

Time frame: Endpoint

Data from ClinicalTrials.gov

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