Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy
1 other identifier
interventional
160
1 country
29
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2005
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJanuary 22, 2021
July 1, 2006
September 8, 2005
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients must not be in poor or unstable health.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Pfizer Investigational Site
Hot Springs, Arkansas, 71913, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
Torrance, California, 90502, United States
Pfizer Investigational Site
Torrance, California, 90509, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Palm Beach Gardens, Florida, 33410, United States
Pfizer Investigational Site
Sunrise, Florida, 33351, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33401, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Boston, Massachusetts, 02115, United States
Pfizer Investigational Site
Omaha, Nebraska, 68116, United States
Pfizer Investigational Site
Omaha, Nebraska, 68131, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89102, United States
Pfizer Investigational Site
Englewood, New Jersey, 07631, United States
Pfizer Investigational Site
New Brunswick, New Jersey, 08903, United States
Pfizer Investigational Site
Albany, New York, 12205, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Rochester, New York, 14642, United States
Pfizer Investigational Site
Greenville, North Carolina, 27834, United States
Pfizer Investigational Site
Toledo, Ohio, 43623, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Dallas, Texas, 75230, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84108, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84132, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2005
Study Completion
May 1, 2006
Last Updated
January 22, 2021
Record last verified: 2006-07