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
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
Exclusion Criteria
- Patients must not be in poor or unstable health.
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
Pfizer Investigational Site🇺🇸San Antonio, Texas, United States