Diabetic Neuropathy, Painful Clinical Trial
Official title:
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Verified date | April 2009 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 167 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Albany | New York |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Denver | Colorado |
United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
United States | Pfizer Investigational Site | Englewood | New Jersey |
United States | Pfizer Investigational Site | Greenville | North Carolina |
United States | Pfizer Investigational Site | Hot Springs | Arkansas |
United States | Pfizer Investigational Site | Houston | Texas |
United States | Pfizer Investigational Site | La Jolla | California |
United States | Pfizer Investigational Site | Lake Worth | Florida |
United States | Pfizer Investigational Site | Las Vegas | Nevada |
United States | Pfizer Investigational Site | New Brunswick | New Jersey |
United States | Pfizer Investigational Site | New Brunswick | New Jersey |
United States | Pfizer Investigational Site | Ocala | Florida |
United States | Pfizer Investigational Site | Ocala | Florida |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Omaha | Nebraska |
United States | Pfizer Investigational Site | Palm Beach Gardens | Florida |
United States | Pfizer Investigational Site | Rochester | New York |
United States | Pfizer Investigational Site | Rochester | New York |
United States | Pfizer Investigational Site | San Antonio | Texas |
United States | Pfizer Investigational Site | Sunrise | Florida |
United States | Pfizer Investigational Site | Toledo | Ohio |
United States | Pfizer Investigational Site | Torrance | California |
United States | Pfizer Investigational Site | Torrance | California |
United States | Pfizer Investigational Site | West Palm Beach | Florida |
United States | Pfizer Investigational Site | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nerve conduction measurements; Pain scores from patient diaries | |||
Secondary | 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 |
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