Expired Study
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Ocala, Florida 34474


Purpose:

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)


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.


Study is Available At:


Original ID:

A0081036


NCT ID:

NCT00159731


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

160


Enrollment Type:


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:January 2005
Completion Date:May 2006
Verification Date:July 2006
Last Changed Date:March 14, 2008
First Received Date:September 8, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Adverse events
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pregabalin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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