Clinical trial NCT00159731: Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
Official title: An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Englewood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: