Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224)
2 other identifiers
interventional
806
16 countries
141
Brief Summary
The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
Typical duration for phase_3
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
January 13, 2016
CompletedJanuary 28, 2021
December 1, 2015
3.5 years
January 4, 2011
October 1, 2015
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Loss of Therapeutic Response.
Loss of Therapeutic Response (LTR) is defined as \<30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of \<30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.
13 Weeks
Secondary Outcomes (16)
Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results
13 Weeks
Percentage of Participants With 30% Reduction in the Mean Pain Score.
13 Weeks
Percentage of Participants With 50% Reduction in the Mean Pain Score.
13 Weeks
Change From Baseline to Endpoint in Weekly Mean Pain Score.
SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Change in the Weekly NRS-Pain (1-Week Recall).
SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
- +11 more secondary outcomes
Study Arms (2)
Pregablain CR tablet 82.5 to 660mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
Eligibility Criteria
You may qualify if:
- Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
- 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
You may not qualify if:
- Creatinine clearance \<30 mL/min (estimated from serum creatinine).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (146)
Fundamental Research
Gulf Shores, Alabama, 36542, United States
Radiant Research, Inc.
Chandler, Arizona, 85224, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
HOPE Research Institute
Phoenix, Arizona, 85018, United States
The Pain Center of Arizona
Phoenix, Arizona, 85018, United States
The Pain Center of Arizona
Phoenix, Arizona, 85027, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Larry Watkins, M.D. (Private Practice)
Little Rock, Arkansas, 72205, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Hearne Family Practice Clinic
Little Rock, Arkansas, 72206, United States
Center for Clinical Research, Inc
Carmichael, California, 95608, United States
Community Medical Providers
Clovis, California, 93611, United States
Sierra Medical Research
Clovis, California, 93612, United States
Inland Pain Medicine
Colton, California, 92324, United States
The Helm Center
Laguna Hills, California, 92637, United States
University of Southern California
Los Angeles, California, 90033, United States
USC IDS Pharmacy
Los Angeles, California, 90089, United States
Translational Research Group, Inc
North Hollywood, California, 91606, United States
George J. Rederich, M.D., Incorporated
Redondo Beach, California, 90277, United States
Integrated Research Group, Inc.
Riverside, California, 92506, United States
Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
San Diego, California, 92117, United States
Integrated Research Center, Inc.
San Diego, California, 92117, United States
Center For Clinical Research, Inc.
San Francisco, California, 94115, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Foothills Pain Management Clinic, PS
West Covina, California, 91790, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, 33012, United States
Laszlo Jozsef Mate, MD
North Palm Beach, Florida, 33408, United States
Family Care Specialists
Ocala, Florida, 34471, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Comprehensive Pain care of South Florida
Royal Palm Beach, Florida, 33411, United States
Comprehensive Clinical Development Inc.
St. Petersburg, Florida, 33716, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
Meridien Research
Tampa, Florida, 33606, United States
Injury Care Medical Center
Boise, Idaho, 83713, United States
Millennium Pain Center, LLC
Bloomington, Illinois, 61701, United States
(IP Shipping Address) Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Chicago Anesthesia Pain Specialists
Chicago, Illinois, 60657, United States
Advanced Pain Care Clinic
Evansville, Indiana, 47714, United States
Clinical Research Advantage
Evansville, Indiana, 47714, United States
Global Scientific Innovations
Evansville, Indiana, 47714, United States
Clinical Trials of America, Inc.
Monroe, Louisiana, 71201, United States
Boston Clinical Trials
Boston, Massachusetts, 02135, United States
Beacon Clinical Research
Brockton, Massachusetts, 02301, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, 02747, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
QUEST Research Institute
Bingham Farms, Michigan, 48025, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114, United States
Clinvest, A Division of Banyan Group, Inc
Springfield, Missouri, 65807, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Montana Medical Research Inc
Missoula, Montana, 59808, United States
Lincoln Internal Medicine Associates
Lincoln, Nebraska, 68516, United States
Drug Shipment Only: Heartland Clinical Research, Inc.
Omaha, Nebraska, 68134, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, 68134, United States
The Office of Dr. Stephen H. Miller, MD
Las Vegas, Nevada, 89144, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
SPRI Clinical Trials LLC
Brooklyn, New York, 11235, United States
Medex Healthcare Research, Inc - Saint Louis
New York, New York, 10036, United States
North American Partners In Pain Management
New York, New York, 11580, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Akron, Ohio, 44311, United States
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, 45439, United States
Wells Institute for Health Awareness
Kettering, Ohio, 45429, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Mark A Fisher
Oklahoma City, Oklahoma, 73112, United States
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, 29412, United States
Arlington Research Center, Inc.
Arlington, Texas, 76011, United States
Lovelace Scientific Resources, Inc.
Austin, Texas, 78758, United States
Radiant Research
Dallas, Texas, 75231, United States
ClinRx Research, LLC
Richardson, Texas, 75080, United States
Hillcrest Family Health Centers, Division of Clinical Research
Waco, Texas, 76710, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53142, United States
DCC "St. Pantaleimon" OOD
Pleven, 5800, Bulgaria
MHAT-Pleven
Pleven, 5800, Bulgaria
MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
Sofia, 1113, Bulgaria
Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
Sofia, 1202, Bulgaria
MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
Sofia, 1407, Bulgaria
Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
Sofia, 1431, Bulgaria
Reumalab S.A.S
Medellín, Antioquia, Colombia
Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME
Bogota, Cundinamarca, 0, Colombia
Fundacion Cardiovascular de Colombia
Floridablanca, Santander Department, 0, Colombia
Opca bolnica Karlovac
Karlovac, Karlovacka Županija, 47000, Croatia
Klinicki Bolnicki Centar Osijek
Osijek, Osjecko-baranjska Županija, 31000, Croatia
Opca bolnica "Dr. Ivo Pedisic"
Sisak, Sisacko-moslavacka Županija, 44000, Croatia
Neurologicka ambulance
Prerov I, 750 02, Czechia
Aalborg Sygehus Nord
Aalborg, North Denmark, DK-900, Denmark
Glostrup Hospital
Glostrup Municipality, DK-2066, Denmark
Schmerzzentrum Frankfurt
Frankfurt am Main, Hesse, 60311, Germany
pro scientia med im MARE Klinikum
Kiel-Kronshagen, Schleswig-Holstein, 24119, Germany
DGS-Schmerzzentrum Eichstätt
Eichstätt, 85072, Germany
Family Medicine
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Medanta Institute of Neurosciences
Gurgaon, Haryana, 122 001, India
Manipal Hospital
Bangalore, Karnataka, 560 017, India
M. S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560 054, India
Mallikatta Neuro Centre
Mangalore, Karnataka, 575002, India
Indraprastha Apollo Hospitals
New Delhi, 110 076, India
"SYNEXUS POLSKA" Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 50088, Poland
Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
Lublin, Lublin Voivodeship, 20022, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 01192, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80286, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81384, Poland
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach
Katowice, Silesian Voivodeship, 40040, Poland
State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
Yaroslavl, Russian Federation, 150023, Russia
State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
Kazan', Tatarstan, Respublika, 119992, Russia
Kazan State Medical University
Kazan', Tatarstan, Respublika, 420064, Russia
GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
Nizhny Novgorod, 603126, Russia
Clinic of Nervous Diseases M.I. Astvatsaturov
Saint Petersburg, 194175, Russia
St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
Saint Petersburg, 197706, Russia
State Budgetary Educational Institution for Higher Professional Education
Smolensk, 214018, Russia
State Budgetary Educational Institution for Higher Professional Education
Smolensk, 214019, Russia
Clinic for Neurology
Belgrade, 11000, Serbia
Clinic for Neurology
Niš, 18000, Serbia
Euro-Neuro s.r.o., Neurologicka ambulancia
Bratislava, 831 03, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
Bratislava, 851 07, Slovakia
MUDr. Eva Gasparova - neurologicka ambulancia
Hlohovec, 920 01, Slovakia
Neurologicka ambulancia, Neuron-DT,s.r.o.
Žilina, 01001, Slovakia
Nelson Mandela Academic Hospital Research Unit
Mthatha, Eastern Cape, 5099, South Africa
Iatros International
Bloemfontein, 9301, South Africa
Synapta Clinical Research Centre
Durban, 4001, South Africa
Mzansi Ethical Research Centre
Middelburg, 1050, South Africa
Jakaranda Pain Clinic
Pretoria, 0014, South Africa
Probare
Lund, Skåne County, 222 22, Sweden
Me3plus Clinical Trials
Gothenburg, 412 63, Sweden
CTC, Sahlgrenska sjukhuset/SU
Gothenburg, 413 45, Sweden
Center for Lakemedelsstudier
Malmo, 211 52, Sweden
Bragee Medect AB
Stockholm, 115 22, Sweden
Chang Gung Medical Foundation-Linkou Branch
Kwei Shan Town, Taoyuan County, 333, Taiwan
National Taiwan University Hospital (Neurology)
Taipei, 100, Taiwan
Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
Kharkiv, 61068, Ukraine
Kyiv City Clinical Hospital #4
Kyiv, 03110, Ukraine
Lviv NMU n.a. Danylo Galytskyy
Lviv, 79013, Ukraine
Regional Municipal Dermatovenerologic Dispensary
Lviv, 79013, Ukraine
Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
Simferopol, 95006, Ukraine
Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
Vinnitsa, 21005, Ukraine
Municipal Establishment "City Clinical Hospital #2", Neurology Department
Zaporizhzhya, 69068, Ukraine
Related Publications (1)
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.
PMID: 27753650DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2011
First Posted
January 5, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2014
Study Completion
November 1, 2014
Last Updated
January 28, 2021
Results First Posted
January 13, 2016
Record last verified: 2015-12