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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 8, 2005
Last updated: March 14, 2008
Last verified: July 2006

September 8, 2005
March 14, 2008
January 2005
Not Provided
Adverse events
Same as current
Complete list of historical versions of study NCT00159731 on Archive Site
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Not Provided
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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
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)
Not Provided
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Peripheral Neuropathy
Drug: Pregabalin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2006
Not Provided

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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc
Not Provided
Study Director: Pfizer Call Center Pfizer
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP