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NCT00159731 Clinical Trial

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

Diabetic Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159731
Other study ID # A0081036
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2005
Est. completion date May 2006

Study information
Verified date July 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date May 2006
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin

Locations
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 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 Las Vegas Nevada
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 Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events
See also
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Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
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