NCT00644748

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	gabapentin	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

Timeline

• Start date: 2003-05-01
• Completion: 2004-08-01
• First posted: 2008-03-27
• Last updated: 2021-02-02

Locations

10 sites across 1 country: Brazil