Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
NCT ID: NCT01270828
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
806 participants
INTERVENTIONAL
2011-03-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pregablain CR tablet 82.5 to 660mg
Pregabalin
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
Placebo
placebo
Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
Interventions
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Pregabalin
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
placebo
Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
Eligibility Criteria
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Inclusion Criteria
* At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
* At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
* Male or female of any race, at least 18 years of age, and using appropriate methods of contraception
Exclusion Criteria
* Skin conditions in the affected dermatome that could alter sensation
* Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
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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Fundamental Research
Gulf Shores, Alabama, United States
Radiant Research, Inc.
Chandler, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Larry Watkins, M.D. (Private Practice)
Little Rock, Arkansas, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Hearne Family Practice Clinic
Little Rock, Arkansas, United States
Center for Clinical Research, Inc
Carmichael, California, United States
Community Medical Providers
Clovis, California, United States
Sierra Medical Research
Clovis, California, United States
Inland Pain Medicine
Colton, California, United States
The Helm Center
Laguna Hills, California, United States
University of Southern California
Los Angeles, California, United States
USC IDS Pharmacy
Los Angeles, California, United States
Translational Research Group, Inc
North Hollywood, California, United States
George J. Rederich, M.D., Incorporated
Redondo Beach, California, United States
Integrated Research Group, Inc.
Riverside, California, United States
Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
San Diego, California, United States
Integrated Research Center, Inc.
San Diego, California, United States
Center For Clinical Research, Inc.
San Francisco, California, United States
Neurological Research Institute
Santa Monica, California, United States
Foothills Pain Management Clinic, PS
West Covina, California, United States
JEM Research Institute
Atlantis, Florida, United States
Orthopedic Research Institute
Boynton Beach, Florida, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, United States
Laszlo Jozsef Mate, MD
North Palm Beach, Florida, United States
Family Care Specialists
Ocala, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Comprehensive Pain care of South Florida
Royal Palm Beach, Florida, United States
Comprehensive Clinical Development Inc.
St. Petersburg, Florida, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Meridien Research
Tampa, Florida, United States
Injury Care Medical Center
Boise, Idaho, United States
Millennium Pain Center, LLC
Bloomington, Illinois, United States
(IP Shipping Address) Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States
Advanced Pain Care Clinic
Evansville, Indiana, United States
Clinical Research Advantage
Evansville, Indiana, United States
Global Scientific Innovations
Evansville, Indiana, United States
Clinical Trials of America, Inc.
Monroe, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Beacon Clinical Research
Brockton, Massachusetts, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
QUEST Research Institute
Bingham Farms, Michigan, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States
Clinvest, A Division of Banyan Group, Inc
Springfield, Missouri, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, United States
Montana Medical Research Inc
Missoula, Montana, United States
Lincoln Internal Medicine Associates
Lincoln, Nebraska, United States
Drug Shipment Only: Heartland Clinical Research, Inc.
Omaha, Nebraska, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States
The Office of Dr. Stephen H. Miller, MD
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Dent Neurological Institute
Amherst, New York, United States
SPRI Clinical Trials LLC
Brooklyn, New York, United States
Medex Healthcare Research, Inc - Saint Louis
New York, New York, United States
North American Partners In Pain Management
New York, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Radiant Research
Akron, Ohio, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, United States
Wells Institute for Health Awareness
Kettering, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Mark A Fisher
Oklahoma City, Oklahoma, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Lovelace Scientific Resources, Inc.
Austin, Texas, United States
Radiant Research
Dallas, Texas, United States
ClinRx Research, LLC
Richardson, Texas, United States
Hillcrest Family Health Centers, Division of Clinical Research
Waco, Texas, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
DCC "St. Pantaleimon" OOD
Pleven, , Bulgaria
MHAT-Pleven
Pleven, , Bulgaria
MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
Sofia, , Bulgaria
Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
Sofia, , Bulgaria
MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
Sofia, , Bulgaria
Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
Sofia, , Bulgaria
Reumalab S.A.S
Medellín, Antioquia, Colombia
Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME
Bogota, Cundinamarca, Colombia
Fundacion Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia
Opca bolnica Karlovac
Karlovac, Karlovacka Županija, Croatia
Klinicki Bolnicki Centar Osijek
Osijek, Osjecko-baranjska Županija, Croatia
Opca bolnica "Dr. Ivo Pedisic"
Sisak, Sisacko-moslavacka Županija, Croatia
Neurologicka ambulance
Prerov I, , Czechia
Aalborg Sygehus Nord
Aalborg, North Denmark, Denmark
Glostrup Hospital
Glostrup Municipality, , Denmark
Schmerzzentrum Frankfurt
Frankfurt am Main, Hesse, Germany
pro scientia med im MARE Klinikum
Kiel-Kronshagen, Schleswig-Holstein, Germany
DGS-Schmerzzentrum Eichstätt
Eichstätt, , Germany
Family Medicine
Hong Kong, , Hong Kong
Queen Elizabeth Hospital
Kowloon, , Hong Kong
Medanta Institute of Neurosciences
Gurgaon, Haryana, India
Manipal Hospital
Bangalore, Karnataka, India
M. S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Mallikatta Neuro Centre
Mangalore, Karnataka, India
Indraprastha Apollo Hospitals
New Delhi, , India
"SYNEXUS POLSKA" Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, Poland
Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
Lublin, Lublin Voivodeship, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, Poland
State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
Yaroslavl, Russian Federation, Russia
State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
Kazan', Tatarstan, Respublika, Russia
Kazan State Medical University
Kazan', Tatarstan, Respublika, Russia
GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
Nizhny Novgorod, , Russia
Clinic of Nervous Diseases M.I. Astvatsaturov
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
Saint Petersburg, , Russia
State Budgetary Educational Institution for Higher Professional Education
Smolensk, , Russia
State Budgetary Educational Institution for Higher Professional Education
Smolensk, , Russia
Clinic for Neurology
Belgrade, , Serbia
Clinic for Neurology
Niš, , Serbia
Euro-Neuro s.r.o., Neurologicka ambulancia
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
Bratislava, , Slovakia
MUDr. Eva Gasparova - neurologicka ambulancia
Hlohovec, , Slovakia
Neurologicka ambulancia, Neuron-DT,s.r.o.
Žilina, , Slovakia
Nelson Mandela Academic Hospital Research Unit
Mthatha, Eastern Cape, South Africa
Iatros International
Bloemfontein, , South Africa
Synapta Clinical Research Centre
Durban, , South Africa
Mzansi Ethical Research Centre
Middelburg, , South Africa
Jakaranda Pain Clinic
Pretoria, , South Africa
Probare
Lund, Skåne County, Sweden
Me3plus Clinical Trials
Gothenburg, , Sweden
CTC, Sahlgrenska sjukhuset/SU
Gothenburg, , Sweden
Center for Lakemedelsstudier
Malmo, , Sweden
Bragee Medect AB
Stockholm, , Sweden
Chang Gung Medical Foundation-Linkou Branch
Kwei Shan Town, Taoyuan County, Taiwan
National Taiwan University Hospital (Neurology)
Taipei, , Taiwan
Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
Kharkiv, , Ukraine
Kyiv City Clinical Hospital #4
Kyiv, , Ukraine
Lviv NMU n.a. Danylo Galytskyy
Lviv, , Ukraine
Regional Municipal Dermatovenerologic Dispensary
Lviv, , Ukraine
Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
Simferopol, , Ukraine
Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
Vinnitsa, , Ukraine
Municipal Establishment "City Clinical Hospital #2", Neurology Department
Zaporizhzhya, , Ukraine
Countries
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References
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Huffman CL, Goldenberg JN, Weintraub J, Sanin L, Driscoll J, Yang R, Chew ML, Scavone JM. Efficacy and Safety of Once-Daily Controlled-Release Pregabalin for the Treatment of Patients With Postherpetic Neuralgia: A Double-Blind, Enriched Enrollment Randomized Withdrawal, Placebo-Controlled Trial. Clin J Pain. 2017 Jul;33(7):569-578. doi: 10.1097/AJP.0000000000000445.
Related Links
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Other Identifiers
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2009-016766-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0081224
Identifier Type: -
Identifier Source: org_study_id
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