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

Phase 4

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Drug: gabapentin

• Registration Number: NCT00644748
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study Completion: 2004-08
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Status Verified: 2008-10
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gabapentin group	gabapentin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline Mean Pain Score	Endpoint

Secondary Outcome Measures

Name	Time	Method
Proportion of responding patients	Endpoint
Change from baseline Mean Pain Score	Weekly
Change from baseline Mean Pain Interference with Sleep Score	Weekly and 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
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

Trial Locations

Locations (1)

Pfizer Investigational Site