Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

NCT ID: NCT01057693

Last Updated: 2021-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

633 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-01-30

Brief Summary

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Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Detailed Description

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Conditions

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Diabetic Neuropathy, Painful

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pregabalin (Lyrica)

Group Type EXPERIMENTAL

pregabalin (Lyrica)

Intervention Type DRUG

Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is supplied as capsules and given 3 times daily.

Interventions

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pregabalin (Lyrica)

Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.

Intervention Type DRUG

Placebo

Placebo is supplied as capsules and given 3 times daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria

* Patients with other pain conditions cannot participate.
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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Greystone Medical Research, LLC

Birmingham, Alabama, United States

Site Status

Neurology Clinic, PC

Northport, Alabama, United States

Site Status

Horizon Clinical Research Associates, PLLC

Gilbert, Arizona, United States

Site Status

Dedicated Clinical Research, Inc.

Goodyear, Arizona, United States

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Dedicated Clinical Research

Goodyear, Arizona, United States

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Novara Clinical Research

Mesa, Arizona, United States

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Arizona Research Center

Phoenix, Arizona, United States

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Radiant Research, Inc.

Scottsdale, Arizona, United States

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Genova Clinical Research, Inc.

Tucson, Arizona, United States

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Central Arkansas Research

Hot Springs, Arkansas, United States

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Little Rock Diagnostic Clinic

Little Rock, Arkansas, United States

Site Status

Convergys Clinical Research, Inc.

Anaheim, California, United States

Site Status

Providence Clinical Research

Burbank, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Center for United Research, Inc.

Lakewood, California, United States

Site Status

Healthcare Partners Medical Group

Los Angeles, California, United States

Site Status

University of Southern California, Keck School of Medicine, Department of Neurology

Los Angeles, California, United States

Site Status

Richard S. Cherlin, MD

Los Gatos, California, United States

Site Status

Northridge Neurological Research

Northridge, California, United States

Site Status

Remek Research

Pomona, California, United States

Site Status

Sierra Clinical Research

Roseville, California, United States

Site Status

CNRI-San Diego, LLC

San Diego, California, United States

Site Status

San Diego Clinical Trials

San Diego, California, United States

Site Status

Center for Clinical Research, Inc.

San Francisco, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

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Neurological Research Institute

Santa Monica, California, United States

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Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Foothills Pain Management

West Covina, California, United States

Site Status

Aurora Family Medicine Center, PC

Aurora, Colorado, United States

Site Status

Alpine Clinical Research Center, Inc.

Boulder, Colorado, United States

Site Status

Mountain View Clinical Research

Denver, Colorado, United States

Site Status

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Site Status

Metabolic Research Institute, Inc.

Boynton Beach, Florida, United States

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Bradenton Research Center

Bradenton, Florida, United States

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Meridien Research

Bradenton, Florida, United States

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Meridien Research

Brooksville, Florida, United States

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Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

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Deerfield Beach Cardiology Research

Deerfield Beach, Florida, United States

Site Status

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

Elite Research Institute

Miami, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Laszlo J. Mate, MD

North Palm Beach, Florida, United States

Site Status

Family Care Specialists, Inc.

Ocala, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, United States

Site Status

Suncoast Clinical Research

Palm Harbor, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Neurology Clinical Research, Inc.

Sunrise, Florida, United States

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Clinical Research of West Florida, Inc.

Tampa, Florida, United States

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Meridien Research

Tampa, Florida, United States

Site Status

Clinical Research of Central Florida

Winter Haven, Florida, United States

Site Status

NeuroTrials Research, Incorporated

Atlanta, Georgia, United States

Site Status

CPM Research Institute

Austell, Georgia, United States

Site Status

Columbus Research Foundation

Columbus, Georgia, United States

Site Status

Rockdale Medical Research Associates

Conyers, Georgia, United States

Site Status

Prism Research Group

Rome, Georgia, United States

Site Status

Valley Health Care

Rome, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

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Advanced Clinical Research

Meridian, Idaho, United States

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AMR Sakeena Research

Aurora, Illinois, United States

Site Status

Chicago Research Center, Inc.

Chicago, Illinois, United States

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American Medical Research, Inc.

Oak Brook, Illinois, United States

Site Status

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

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American Health Network

Greenfield, Indiana, United States

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Rehabilitation Associates of Indiana

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

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Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Kentucky Medical Research Center

Lexington, Kentucky, United States

Site Status

Endocrinology Center of Southwest Louisiana

Lake Charles, Louisiana, United States

Site Status

Heartland Research, LLC

Lake Charles, Louisiana, United States

Site Status

Primary Physician Care, LLC

Lake Charles, Louisiana, United States

Site Status

Arthritis and Diabetes Clinic, Inc

Monroe, Louisiana, United States

Site Status

Miray Medical Center

Brockton, Massachusetts, United States

Site Status

Clinical Research Center of Cape Cod, Inc.

Hyannis, Massachusetts, United States

Site Status

MedVadis Research Corporation

Watertown, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Site Status

Harris and Associates MD, PC

Detroit, Michigan, United States

Site Status

Borgess Diabetes Center

Kalamazoo, Michigan, United States

Site Status

Borgess Research Institute

Kalamazoo, Michigan, United States

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William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

KMED Research

Saint Clair Shores, Michigan, United States

Site Status

William Beaumont Hospital

Troy, Michigan, United States

Site Status

Troy Internal Medicine, PC

Troy, Michigan, United States

Site Status

MAPS Applied Research Center, Inc.

Edina, Minnesota, United States

Site Status

Medical Advanced Pain Specialists (MAPS)

Edina, Minnesota, United States

Site Status

Medical Advanced Pain Specialists

Maple Grove, Minnesota, United States

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Medical Advanced Pain Specialists

Shakopee, Minnesota, United States

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CRC of Jackson

Jackson, Mississippi, United States

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Physician's Surgery Center

Jackson, Mississippi, United States

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Randall T. Huling, Jr., MD, CPI

Olive Branch, Mississippi, United States

Site Status

University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center

Columbia, Missouri, United States

Site Status

Melinda A. Crockett-Maples

Marionville, Missouri, United States

Site Status

Clinvest

Springfield, Missouri, United States

Site Status

A & A Pain Institute of Saint Louis

St Louis, Missouri, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Lincoln Internal Medicine Associates

Lincoln, Nebraska, United States

Site Status

Desert Endocrinology Clinical Research Center

Henderson, Nevada, United States

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Desert Endocrinology

Las Vegas, Nevada, United States

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Office of Dr. Danka Michaels, MD

Las Vegas, Nevada, United States

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Office of Stephen Miller, M.D.

Las Vegas, Nevada, United States

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Raleigh Neurology Associates, P.A.

Raleigh, North Carolina, United States

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Carolina Pharmaceutical Research

Statesville, North Carolina, United States

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Radiant Research, Inc.

Akron, Ohio, United States

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Community Research

Cincinnati, Ohio, United States

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Radiant Research

Cincinnati, Ohio, United States

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Hometown Urgent Care and Research

Dayton, Ohio, United States

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Providence Health Partners - Center for Clinical Research

Dayton, Ohio, United States

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Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Veronique Sebastian, MD

Oklahoma City, Oklahoma, United States

Site Status

Angelique Barreto, MD

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Blair Orthopedic Associates, Inc.

Altoona, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

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Research Protocol Management Specialists

Pittsburgh, Pennsylvania, United States

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Coastal Medical

East Greenwich, Rhode Island, United States

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Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Omega Medical Research

Warwick, Rhode Island, United States

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Aiken Center for Clinical Research

Aiken, South Carolina, United States

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TLM Medical Services, LLC

Columbia, South Carolina, United States

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Radiant Research Inc.

Greer, South Carolina, United States

Site Status

Neurology and Pain Clinic, LLC

Orangeburg, South Carolina, United States

Site Status

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, United States

Site Status

SCRI Research Center

Germantown, Tennessee, United States

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Sarah Cannon Research Institute

Jackson, Tennessee, United States

Site Status

AM Diabetes & Endocrinology Center

Memphis, Tennessee, United States

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Memphis Internal Medicine

Memphis, Tennessee, United States

Site Status

ClinRx Research LLC

Carrollton, Texas, United States

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Baylor University Medical Center

Dallas, Texas, United States

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University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

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Medical Group of Texas

Fort Worth, Texas, United States

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The Nerve and Muscle Center of Texas

Houston, Texas, United States

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ClinRx Research, LLC

Richardson, Texas, United States

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Paragon Research Center, LLC

San Antonio, Texas, United States

Site Status

Alamo Clinical Research

San Antonio, Texas, United States

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Cetero Research - San Antonio

San Antonio, Texas, United States

Site Status

Pioneer Research Solutions, Inc

Sugar Land, Texas, United States

Site Status

L. Craig Larsen and Clark C. Larsen

Murray, Utah, United States

Site Status

Aspen Clinical Research

Orem, Utah, United States

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Daniel B. Vine, MD

Salt Lake City, Utah, United States

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Wasatch Clinical Research

Salt Lake City, Utah, United States

Site Status

Jean Brown Research

Salt Lake City, Utah, United States

Site Status

Foot and Ankle Clinic

West Jordan, Utah, United States

Site Status

Neurological Associates, Incorporated

Henrico, Virginia, United States

Site Status

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, United States

Site Status

Spokane Internal Medicine

Spokane, Washington, United States

Site Status

Aurora Advanced Healthcare, Inc.

Milwaukee, Wisconsin, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

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Winnipeg Health Sciences Centre

Winnipeg, Manitoba, Canada

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Winnipeg Regional Health Authority Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

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Capital District Health Authority, QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Capital District Health Authority, QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

The Ottawa Hospital, Riverside Campus - Riverside Professional Building

Ottawa, Ontario, Canada

Site Status

Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Ponce School of Medicine & Health Sciences

Ponce, , Puerto Rico

Site Status

Instituto de Endocrinologia Diabetes y Metabolismo

Toa Baja, , Puerto Rico

Site Status

Bloemfontein Medi-Clinic

Bloemfontein, Free State, South Africa

Site Status

Dr Makan's Rooms

Johannesburg, Gauteng, South Africa

Site Status

Chris Hani Baragwanath Hospital

Soweto, Gauteng, South Africa

Site Status

Randles Road Medical Centre

Durban, KwaZulu-Natal, South Africa

Site Status

Chelmsford Medical Centre

Durban, KwaZulu-Natal, South Africa

Site Status

Centre for Diabetes and Endocrinology

Durban, KwaZulu-Natal, South Africa

Site Status

Dr Jeevren Reddy's Surgery

KwaDukuza, KwaZulu-Natal, South Africa

Site Status

Parklands Medical Centre

Overport, KwaZulu-Natal, South Africa

Site Status

Dot Shuttleworth Centre for Diabetes

Durban, Overport, South Africa

Site Status

Centre for Diabetes and Endocrinology

Houghton, Johannesburg, , South Africa

Site Status

102 Parklands Medical Centre

Overport, Durban, , South Africa

Site Status

Dr's Sauermann and Meyer

Polokwane, , South Africa

Site Status

Diabetes Care Centre

Pretoria, , South Africa

Site Status

Countries

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United States Canada Puerto Rico South Africa

References

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Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.

Reference Type DERIVED
PMID: 23887339 (View on PubMed)

Related Links

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Other Identifiers

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2009-017389-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A0081242

Identifier Type: -

Identifier Source: org_study_id

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