Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Phase 4

Completed

• Conditions: Diabetic Peripheral Neuropathy

• Registration Number: NCT00159731
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-12
• Study Completion: 2006-05
• Status Verified: 2006-07
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Exclusion Criteria

• Patients must not be in poor or unstable health.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Salt Lake City, Utah, United States