An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country160 target enrollmentJanuary 2005

ConditionsDiabetic Peripheral Neuropathy

DrugsPregabalin

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diabetic Peripheral Neuropathy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 160
Locations: 1
Primary Endpoint: Adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

May 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults with Type 1 or 2 diabetes
•Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months