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

NCT ID: NCT00159731

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-05-31

Brief Summary

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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

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Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pregabalin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hot Springs, Arkansas, United States

Site Status

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La Jolla, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Palm Beach Gardens, Florida, United States

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Sunrise, Florida, United States

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West Palm Beach, Florida, United States

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West Palm Beach, Florida, United States

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Boston, Massachusetts, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Englewood, New Jersey, United States

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New Brunswick, New Jersey, United States

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Albany, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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Greenville, North Carolina, United States

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Toledo, Ohio, United States

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Duncansville, Pennsylvania, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Pfizer Investigational Site

Salt Lake City, Utah, United States

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Countries

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United States

Related Links

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Other Identifiers

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A0081036

Identifier Type: -

Identifier Source: org_study_id

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