Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
NCT ID: NCT01474772
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2011-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Pregabain
Pregabalin
150-300 mg/day given in 3 divided doses as capsules
Placebo
placebo
matching placebo capsules given in 3 divided doses
Interventions
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Pregabalin
150-300 mg/day given in 3 divided doses as capsules
placebo
matching placebo capsules given in 3 divided doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of painful diabetic peripheral neuropathy.
* Pain on walking.
Exclusion Criteria
* Pain on walking due to conditions other than diabetic peripheral neuropathy.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Dedicated Clinical Research
Goodyear, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Neuro-Pain Medical Center
Fresno, California, United States
HealthCare Partners Medical Group
Los Angeles, California, United States
IDS Pharmacy
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
PAB Clinical Research
Brandon, Florida, United States
Pulmonary Associates of Brandon
Brandon, Florida, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
The Office of Laszlo Jozef Mate, MD
North Palm Beach, Florida, United States
Meridien Research
Tampa, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Columbus Research Foundation
Columbus, Georgia, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Desert Endocrinology Clinical Research Center
Henderson, Nevada, United States
Clinical Research Consortium
Las Vegas, Nevada, United States
The Office of Dr. Stephen H. Miller, MD
Las Vegas, Nevada, United States
The Medical Research Network, LLC
New York, New York, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
The Office of Veronique Sebastian, MD
Oklahoma City, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Oregon Health and Science University - Comprehensive Pain Center
Portland, Oregon, United States
Oregon Health and Science University - Department of Anesthesiology and Perioperative Medicine
Portland, Oregon, United States
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Neurology and Pain Clinic, LLC
Orangeburg, South Carolina, United States
Houston Neurocare
Houston, Texas, United States
Centex Research, Inc.
Houston, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Privatni specializovana ambulance pro neurologii a detskou neurologii
Brno-Bystrc, , Czechia
Clintrial, s.r.o.
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Dr DR Lakha's Practice
Johannesburg, Gauteng, South Africa
Dr Hemant Makan (Private Practice)
Lenasia, Gauteng, South Africa
Randles Road Medical Centre
Durban, KwaZulu-Natal, South Africa
Richards Bay Trial Centre
Richards Bay, , South Africa
Forskningsmottagningen Gamla Sjukhuset i Falkoping
Falköping, , Sweden
Center for Lakemedelsstudier
Malmo, , Sweden
Citydiabetes
Stockholm, , Sweden
Bragee Medect AB
Stockholm, , Sweden
Countries
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References
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Huffman C, Stacey BR, Tuchman M, Burbridge C, Li C, Parsons B, Pauer L, Scavone JM, Behar R, Yurkewicz L. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015 Nov;31(11):946-58. doi: 10.1097/AJP.0000000000000198.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-003266-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0081269
Identifier Type: -
Identifier Source: org_study_id
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