NCT00553280

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Conditions

• Diabetic Neuropathy, Painful

Interventions

Type	Name	Description
DRUG	pregabalin	Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-11-05
• Last updated: 2021-01-25
• Results posted: 2011-01-05

Locations

27 sites across 1 country: Japan