Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Phase 4

Completed

• Conditions: Diabetic Neuropathy, Painful

• Registration Number: NCT00159679
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Completion: 2005-10
• Status Verified: 2009-04
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

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Exclusion Criteria

• Patients must not be in poor or unstable health.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nerve conduction measurements; Pain scores from patient diaries

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States