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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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