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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 8, 2005

Last Updated Date

March 14, 2008

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

Adverse events

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00159731 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

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)

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Diabetic Peripheral Neuropathy

Intervention ^†

Drug: Pregabalin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

160

Completion Date

May 2006

Primary Completion Date

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00159731

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.