Clinical trial NCT01057693: Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Official title: A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetic peripheral neuropathy
Lyrica
pregabalin
pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
timeFrame: SB Baseline, Week 19 (DB Phase)
Secondary outcomes:
measure: Time to Loss of Pain Response (Double-Blind Phase)
timeFrame: SB Baseline up to Week 19
measure: Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase
timeFrame: SB Baseline, Week 6 (SB Phase)
measure: Weekly Mean Pain Scores (Single-Blind Phase)
timeFrame: Week 1, 2, 3, 4, 5, 6
measure: Weekly Mean Pain Scores (Double-Blind Phase)
timeFrame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
measure: Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)
timeFrame: Week 6
measure: Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)
timeFrame: Week 19
measure: Patient Global Impression of Change (PGIC) (Single-Blind Phase)
timeFrame: Week 6
measure: Patient Global Impression of Change (PGIC) (Double-Blind Phase)
timeFrame: Week 19
measure: Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)
timeFrame: SB Baseline, Week 6
measure: Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)
timeFrame: Week 19
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)
timeFrame: SB Baseline, Week 6
measure: Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)
timeFrame: Week 19
measure: Weekly Mean Sleep Interference Score (Single-Blind Phase)
timeFrame: SB Baseline, Week 1, 2, 3, 4, 5, 6
measure: Weekly Mean Sleep Interference Score (Double-Blind Phase)
timeFrame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
measure: Endpoint Mean Sleep Interference Score (Single-Blind Phase)
timeFrame: Week 6
measure: Endpoint Mean Sleep Interference Score (Double-Blind Phase)
timeFrame: Week 19
measure: Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)
timeFrame: SB Baseline, Week 6
measure: Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)
timeFrame: Week 19
measure: Pain Visual Analog Scale (VAS) (Single-Blind Phase)
timeFrame: SB Baseline, Week 6
measure: Pain Visual Analog Scale (VAS) (Double-Blind Phase)
timeFrame: Week 19
measure: Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)
timeFrame: SB Baseline, Week 6
measure: Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)
timeFrame: Week 19
measure: Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)
timeFrame: SB Baseline, Week 6
measure: Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)
timeFrame: Week 19
measure: Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)
timeFrame: Week 6
measure: Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)
timeFrame: Week 19
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Greystone Medical Research, LLC
state: Alabama
city: Northport
country: United States
facility: Neurology Clinic, PC
state: Alabama
city: Gilbert
country: United States
facility: Horizon Clinical Research Associates, PLLC
state: Arizona
city: Goodyear
country: United States
facility: Dedicated Clinical Research, Inc.
state: Arizona
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Mesa
country: United States
facility: Novara Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: Central Arkansas Research
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Diagnostic Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Convergys Clinical Research, Inc.
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Lakewood
country: United States
facility: Center for United Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Los Angeles
country: United States
facility: University of Southern California, Keck School of Medicine, Department of Neurology
state: California
city: Los Gatos
country: United States
facility: Richard S. Cherlin, MD
state: California
city: Northridge
country: United States
facility: Northridge Neurological Research
state: California
city: Pomona
country: United States
facility: Remek Research
state: California
city: Roseville
country: United States
facility: Sierra Clinical Research
state: California
city: San Diego
country: United States
facility: CNRI-San Diego, LLC
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: West Covina
country: United States
facility: Foothills Pain Management
state: California
city: Aurora
country: United States
facility: Aurora Family Medicine Center, PC
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center, Inc.
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Boynton Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Deerfield Beach
country: United States
facility: Deerfield Beach Cardiology Research
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J. Mate, MD
state: Florida
city: Ocala
country: United States
facility: Family Care Specialists, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center, Advanced Research Consultants, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Incorporated
state: Georgia
city: Austell
country: United States
facility: CPM Research Institute
state: Georgia
city: Columbus
country: United States
facility: Columbus Research Foundation
state: Georgia
city: Conyers
country: United States
facility: Rockdale Medical Research Associates
state: Georgia
city: Rome
country: United States
facility: Prism Research Group
state: Georgia
city: Rome
country: United States
facility: Valley Health Care
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Aurora
country: United States
facility: AMR Sakeena Research
state: Illinois
city: Chicago
country: United States
facility: Chicago Research Center, Inc.
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Greenfield
country: United States
facility: American Health Network
state: Indiana
city: Indianapolis
country: United States
facility: Rehabilitation Associates of Indiana
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Kentucky Medical Research Center
state: Kentucky
city: Lake Charles
country: United States
facility: Endocrinology Center of Southwest Louisiana
state: Louisiana
city: Lake Charles
country: United States
facility: Heartland Research, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Primary Physician Care, LLC
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc
state: Louisiana
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Clinical Research Center of Cape Cod, Inc.
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Detroit
country: United States
facility: Harris and Associates MD, PC
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Diabetes Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Clair Shores
country: United States
facility: KMED Research
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Troy Internal Medicine, PC
state: Michigan
city: Edina
country: United States
facility: MAPS Applied Research Center, Inc.
state: Minnesota
city: Edina
country: United States
facility: Medical Advanced Pain Specialists (MAPS)
state: Minnesota
city: Maple Grove
country: United States
facility: Medical Advanced Pain Specialists
state: Minnesota
city: Shakopee
country: United States
facility: Medical Advanced Pain Specialists
state: Minnesota
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Jackson
country: United States
facility: Physician's Surgery Center
state: Mississippi
city: Olive Branch
country: United States
facility: Randall T. Huling, Jr., MD, CPI
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center
state: Missouri
city: Marionville
country: United States
facility: Melinda A. Crockett-Maples
state: Missouri
city: Saint Louis
country: United States
facility: A & A Pain Institute of Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: Lincoln
country: United States
facility: Lincoln Internal Medicine Associates
state: Nebraska
city: Henderson
country: United States
facility: Desert Endocrinology Clinical Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Desert Endocrinology
state: Nevada
city: Las Vegas
country: United States
facility: Office of Dr. Danka Michaels, MD
state: Nevada
city: Las Vegas
country: United States
facility: Office of Stephen Miller, M.D.
state: Nevada
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Statesville
country: United States
facility: Carolina Pharmaceutical Research
state: North Carolina
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veronique Sebastian, MD
state: Oklahoma
city: Oklahoma City
country: United States
facility: Angelique Barreto, MD
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Altoona
country: United States
facility: Blair Orthopedic Associates, Inc.
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists
state: Pennsylvania
city: East Greenwich
country: United States
facility: Coastal Medical
state: Rhode Island
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Aiken
country: United States
facility: Aiken Center for Clinical Research
state: South Carolina
city: Columbia
country: United States
facility: TLM Medical Services, LLC
state: South Carolina
city: Greer
country: United States
facility: Radiant Research Inc.
state: South Carolina
city: Orangeburg
country: United States
facility: Neurology and Pain Clinic, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: University Diabetes & Endocrine Consultants
state: Tennessee
city: Germantown
country: United States
facility: SCRI Research Center
state: Tennessee
city: Jackson
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Memphis
country: United States
facility: AM Diabetes & Endocrinology Center
state: Tennessee
city: Memphis
country: United States
facility: Memphis Internal Medicine
state: Tennessee
city: Carrollton
country: United States
facility: ClinRx Research LLC
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Medical Group of Texas
state: Texas
city: Houston
country: United States
facility: The Nerve and Muscle Center of Texas
state: Texas
city: Richardson
country: United States
facility: ClinRx Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center, LLC
state: Texas
city: San Antonio
country: United States
facility: Alamo Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Cetero Research - San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions, Inc
state: Texas
city: Murray
country: United States
facility: L. Craig Larsen and Clark C. Larsen
state: Utah
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Daniel B. Vine, MD
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: West Jordan
country: United States
facility: Foot and Ankle Clinic
state: Utah
city: Henrico
country: United States
facility: Neurological Associates, Incorporated
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Spokane
country: United States
facility: Spokane Internal Medicine
state: Washington
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc.
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority Sciences Centre Winnipeg
state: Manitoba
city: Halifax
country: Canada
facility: Capital District Health Authority, QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Capital District Health Authority, QEII Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Riverside Campus - Riverside Professional Building
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine & Health Sciences
city: Toa Baja
country: Puerto Rico
facility: Instituto de Endocrinologia Diabetes y Metabolismo
city: Bloemfontein
country: South Africa
facility: Bloemfontein Medi-Clinic
state: FREE State
city: Johannesburg
country: South Africa
facility: Dr Makan's Rooms
state: Gauteng
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Hospital
state: Gauteng
city: Durban
country: South Africa
facility: Randles Road Medical Centre
state: Kwa-zulu Natal
city: Durban
country: South Africa
facility: Chelmsford Medical Centre
state: Kwazulu Natal
city: Durban
country: South Africa
facility: Centre for Diabetes and Endocrinology
state: Kwazulu Natal
city: Overport
country: South Africa
facility: Parklands Medical Centre
state: Kwazulu Natal
city: Stanger
country: South Africa
facility: Dr Jeevren Reddy's Surgery
state: Kwazulu Natal
city: Durban
country: South Africa
facility: Dot Shuttleworth Centre for Diabetes
state: Overport
city: Houghton, Johannesburg
country: South Africa
facility: Centre for Diabetes and Endocrinology
city: Overport, Durban
country: South Africa
facility: 102 Parklands Medical Centre
city: Polokwane
country: South Africa
facility: Dr's Sauermann and Meyer
city: Pretoria
country: South Africa
facility: Diabetes Care Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.