Clinical trial NCT01270828: Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Herpetic Neuralgia
Keywords: Control Release Pregabalin in Post Herpetic Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 806
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Loss of Therapeutic Response.
timeFrame: 13 Weeks
Secondary outcomes:
measure: Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results
timeFrame: 13 Weeks
measure: Percentage of Participants With 30% Reduction in the Mean Pain Score.
timeFrame: 13 Weeks
measure: Percentage of Participants With 50% Reduction in the Mean Pain Score.
timeFrame: 13 Weeks
measure: Change From Baseline to Endpoint in Weekly Mean Pain Score.
timeFrame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
measure: Change in the Weekly NRS-Pain (1-Week Recall).
timeFrame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
measure: Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).
timeFrame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
measure: Change in the MOS-SS-Quantity of Sleep.
timeFrame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
measure: The MOS-SS-Optimal Sleep.
timeFrame: Week 6 and Week 19
measure: Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score
timeFrame: Week 19
measure: Change in the Short Form 36 Health Survey (SF-36)
timeFrame: Week 19
measure: Change in Mean Daily Sleep Interference Scores
timeFrame: Week 19
measure: Change in Hospital Anxiety and Depression Scales (HADS)
timeFrame: Week 19
measure: Change in the Brief Pain Inventory (BPI-sf)
timeFrame: Week 19
measure: Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)
timeFrame: Week 19
measure: Number of Participants With Adverse Events
timeFrame: Baseline to Week 20
measure: Percentage of Participants With Suicidal Behaviour/Ideation
timeFrame: Baseline, Weeks 6, 11, 15, 19 and 20
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: Fundamental Research
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Larry Watkins, M.D. (Private Practice)
state: Arkansas
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: Hearne Family Practice Clinic
state: Arkansas
city: Carmichael
country: United States
facility: Center for Clinical Research, Inc
state: California
city: Clovis
country: United States
facility: Community Medical Providers
state: California
city: Clovis
country: United States
facility: Sierra Medical Research
state: California
city: Colton
country: United States
facility: Inland Pain Medicine
state: California
city: Laguna Hills
country: United States
facility: The Helm Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: USC IDS Pharmacy
state: California
city: North Hollywood
country: United States
facility: Translational Research Group, Inc
state: California
city: Redondo Beach
country: United States
facility: George J. Rederich, M.D., Incorporated
state: California
city: Riverside
country: United States
facility: Integrated Research Group, Inc.
state: California
city: San Diego
country: United States
facility: Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
state: California
city: San Diego
country: United States
facility: Integrated Research Center, Inc.
state: California
city: San Francisco
country: United States
facility: Center For Clinical Research, Inc.
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: West Covina
country: United States
facility: Foothills Pain Management Clinic, PS
state: California
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
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: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research Center
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo Jozsef Mate, MD
state: Florida
city: Ocala
country: United States
facility: Family Care Specialists
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: Royal Palm Beach
country: United States
facility: Comprehensive Pain care of South Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Clinical Development Inc.
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: Boise
country: United States
facility: Injury Care Medical Center
state: Idaho
city: Bloomington
country: United States
facility: Millennium Pain Center, LLC
state: Illinois
city: Chicago
country: United States
facility: (IP Shipping Address) Advocate Illinois Masonic Medical Center
state: Illinois
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
city: Evansville
country: United States
facility: Advanced Pain Care Clinic
state: Indiana
city: Evansville
country: United States
facility: Clinical Research Advantage
state: Indiana
city: Evansville
country: United States
facility: Global Scientific Innovations
state: Indiana
city: Monroe
country: United States
facility: Clinical Trials of America, Inc.
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain & Neurological Institute
state: Michigan
city: Bingham Farms
country: United States
facility: QUEST Research Institute
state: Michigan
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, PC
state: Missouri
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Springfield
country: United States
facility: Clinvest, A Division of Banyan Group, Inc
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research Inc
state: Montana
city: Lincoln
country: United States
facility: Lincoln Internal Medicine Associates
state: Nebraska
city: Omaha
country: United States
facility: Drug Shipment Only: Heartland Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: The Office of Dr. Stephen H. Miller, MD
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurological Institute
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials LLC
state: New York
city: New York
country: United States
facility: Medex Healthcare Research, Inc - Saint Louis
state: New York
city: New York
country: United States
facility: North American Partners In Pain Management
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners-Center for Clinical Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mark A Fisher
state: Oklahoma
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials, Inc.
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Austin
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Texas
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Richardson
country: United States
facility: ClinRx Research, LLC
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Centers, Division of Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
city: Pleven
country: Bulgaria
facility: DCC "St. Pantaleimon" OOD
city: Pleven
country: Bulgaria
facility: MHAT-Pleven
city: Sofia
country: Bulgaria
facility: MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
city: Sofia
country: Bulgaria
facility: Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
city: Sofia
country: Bulgaria
facility: MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
city: Sofia
country: Bulgaria
facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
city: Medellin
country: Colombia
facility: Reumalab S.A.S
state: Antioquia
city: Bogota
country: Colombia
facility: Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia
state: Santander
city: Karlovac
country: Croatia
facility: Opca bolnica Karlovac
state: Karlovacka Županija
city: Osijek
country: Croatia
facility: Klinicki Bolnicki Centar Osijek
state: Osjecko-baranjska Županija
city: Sisak
country: Croatia
facility: Opca bolnica "Dr. Ivo Pedisic"
state: Sisacko-moslavacka Županija
city: Prerov I
country: Czechia
facility: Neurologicka ambulance
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Nord
state: Region Nordjylland
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Frankfurt/Main
country: Germany
facility: Schmerzzentrum Frankfurt
state: Hessen
city: Kiel-Kronshagen
country: Germany
facility: pro scientia med im MARE Klinikum
state: Schleswig-Holstein
city: Eichstaett
country: Germany
facility: DGS-Schmerzzentrum Eichstätt
city: Hong Kong
country: Hong Kong
facility: Family Medicine
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Gurgaon
country: India
facility: Medanta Institute of Neurosciences
state: Haryana
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Bangalore
country: India
facility: M. S. Ramaiah Medical College and Hospitals
state: Karnataka
city: Mangalore
country: India
facility: Mallikatta Neuro Centre
state: Karnataka
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
city: Wroclaw
country: Poland
facility: "SYNEXUS POLSKA" Sp. z o.o.
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
state: Lubelskie
city: Warszawa
country: Poland
facility: "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Gdansk
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
state: Pomorskie
city: Gdynia
country: Poland
facility: "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
state: Pomorskie
city: Katowice
country: Poland
facility: "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach
state: Slaskie
city: Kazan
country: Russian Federation
facility: State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
state: Tatarstan, Respublika
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Tatarstan, Respublika
city: Nizhny Novgorod
country: Russian Federation
facility: GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
city: Saint-Petersburg
country: Russian Federation
facility: Clinic of Nervous Diseases M.I. Astvatsaturov
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
city: Smolensk
country: Russian Federation
facility: State Budgetary Educational Institution for Higher Professional Education
city: Smolensk
country: Russian Federation
facility: State Budgetary Educational Institution for Higher Professional Education
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
city: Belgrade
country: Serbia
facility: Clinic for Neurology
city: Nis
country: Serbia
facility: Clinic for Neurology
city: Bratislava
country: Slovakia
facility: Euro-Neuro s.r.o., Neurologicka ambulancia
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
city: Hlohovec
country: Slovakia
facility: MUDr. Eva Gasparova - neurologicka ambulancia
city: Zilina
country: Slovakia
facility: Neurologicka ambulancia, Neuron-DT,s.r.o.
city: Mthatha
country: South Africa
facility: Nelson Mandela Academic Hospital Research Unit
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Iatros International
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
city: Middelburg
country: South Africa
facility: Mzansi Ethical Research Centre
city: Pretoria
country: South Africa
facility: Jakaranda Pain Clinic
city: Lund
country: Sweden
facility: Probare
state: Skane Lan
city: Goteborg
country: Sweden
facility: Me3plus Clinical Trials
city: Goteborg
country: Sweden
facility: CTC, Sahlgrenska sjukhuset/SU
city: Malmo
country: Sweden
facility: Center for Lakemedelsstudier
city: Stockholm
country: Sweden
facility: Bragee Medect AB
city: Kwei Shan Town
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
state: Taoyuan County
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (Neurology)
city: Kharkiv
country: Ukraine
facility: Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #4
city: Lviv
country: Ukraine
facility: Lviv NMU n.a. Danylo Galytskyy
city: Lviv
country: Ukraine
facility: Regional Municipal Dermatovenerologic Dispensary
city: Simferopol
country: Ukraine
facility: Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
city: Vinnitsa
country: Ukraine
facility: Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
city: Zaporizhzhya
country: Ukraine
facility: Municipal Establishment "City Clinical Hospital #2", Neurology Department
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.