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

Viatris

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathies

Treatments: Drug: gabapentin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644748

A9451004

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Gabapentin group

Experimental group

Treatment:

Drug: gabapentin