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Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Herpetic Neuralgia

Intervention: Pregabalin (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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)

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time to loss of therapeutic response (LTR), defined as <30% pain response relative to the baseline phase or patient discontinuation due to lack of efficacy or adverse events, in the double blind phase of the study.

Secondary outcome:

Pain numeric rating scale (NRS); 1 week recall period

Medical Outcomes Study (MOS) Sleep Scale total score and each sub domain

Patient Global Impression of Change (PGIC).

Short Form 36 Health Survey (SF 36).

Daily sleep interference diary

Hospital Anxiety and Depression Scale (HADS).

Brief Pain Inventory (BPI sf).

Benefit, Satisfaction, Willingness to Continue Measure (BSW).

Adverse events.

Suicidality assessments (STS).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

DCC "St. Pantaleimon" OOD, Pleven 5800, Bulgaria

MHAT-Pleven, Pleven 5800, Bulgaria

MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya, Sofia 1407, Bulgaria

MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia, Sofia 1113, Bulgaria

Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia, Sofia 1431, Bulgaria

Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie, Sofia 1202, Bulgaria

Neurologicka ambulance, Prerov I 750 02, Czech Republic

Glostrup Hospital, Glostrup DK-2066, Denmark

DGS-Schmerzzentrum Eichstätt, Eichstaett 85072, Germany

Family Medicine, Hong Kong, Hong Kong

Queen Elizabeth Hospital, Kowloon, Hong Kong

Indraprastha Apollo Hospitals, New Delhi 110 076, India

GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod 603126, Russian Federation

Clinic of Nervous Diseases M.I. Astvatsaturov, Saint-Petersburg 194175, Russian Federation

St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona, Saint-Petersburg 197706, Russian Federation

State Budgetary Educational Institution for Higher Professional Education, Smolensk 214018, Russian Federation

State Budgetary Educational Institution for Higher Professional Education, Smolensk 214019, Russian Federation

State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10", Yaroslavl 150023, Russian Federation

Clinic for Neurology, Belgrade 11000, Serbia

Clinic for Neurology, Nis 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., Zilina 01001, Slovakia

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

CTC, Sahlgrenska sjukhuset/SU, Goteborg 413 45, Sweden

Me3plus Clinical Trials, Goteborg 412 63, Sweden

Center for Lakemedelsstudier, Malmo 211 52, Sweden

Bragee Medect AB, Stockholm 115 22, Sweden

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

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

Fundamental Research, Gulf Shores, Alabama 36542, United States

Reumalab S.A.S, Medellin, Antioquia, Colombia

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

Hearne Family Practice Clinic, Little Rock, Arkansas 72206, 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

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

Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME, Bogota, Cundinamarca, Colombia

Synexus Polska Sp. z o.o., Wroclaw, Dolnoslaskie 50-088, Poland

Nelson Mandela Academic Hospital Research Unit, Mthatha, Eastern Cape 5099, South Africa

JEM Research Institute, Atlantis, Florida 33462, United States

Orthopedic Research Institute, Boynton Beach, Florida 33472, United States

Clinical Research of West Florida, Inc., Clearwater, Florida 33765, United States

Innovative Research of West Florida, Inc., Clearwater, Florida 33756, 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

Medanta Institute of Neurosciences, Gurgaon, Haryana 122 001, India

Schmerzzentrum Frankfurt, Frankfurt/Main, Hessen 60311, Germany

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

Opca bolnica Karlovac, Karlovac, Karlovacka županija 47000, Croatia

M. S. Ramaiah Medical College and Hospitals, Bangalore, Karnataka 560 054, India

Manipal Hospital, Bangalore, Karnataka 560 017, India

Mallikatta Neuro Centre, Mangalore, Karnataka 575002, India

Clinical Trials of America, Inc., Monroe, Louisiana 71201, United States

Prywatna Praktyka Lek. Gab. Reumatology, Lublin, Lubelskie 20-022, Poland

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

Synexus Polska Sp. z o. o, Warszawa, Mazowieckie 01-192, Poland

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

Medex Healthcare Research, Inc., Saint Louis, Missouri 63117, United States

Clinvest, A Division of Banyan Group, Inc, Springfield, Missouri 65807, 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

Klinicki Bolnicki Centar Osijek, Osijek, Osjecko-baranjska županija 31000, Croatia

NZOZ "Przychodnia Morena", Gdansk, Pomorskie 80-286, Poland

Synexus Polska Sp. z o.o., Oddział w Gdyni, Gdynia, Pomorskie 81-384, Poland

Aalborg Sygehus Nord, Aalborg, Region Nordjylland DK-900, Denmark

Fundacion Cardiovascular de Colombia, Floridablanca, Santander, Colombia

pro scientia med im MARE Klinikum, Kiel-Kronshagen, Schleswig-Holstein 24119, Germany

Opca bolnica "Dr. Ivo Pedisic", Sisak, Sisacko-moslavacka županija 44000, Croatia

Probare, Lund, Skane lan 222 22, Sweden

Synexus Polska Sp. z o.o., Katowice, Slaskie 40-040, Poland

Pharmacorp Clinical Trials, Inc., Charleston, South Carolina 29412, United States

Chang Gung Medical Foundation-Linkou Branch, Kwei Shan Town, Taoyuan County 333, Taiwan

Kazan State Medical University, Kazan, Tatarstan, Respublika 420064, Russian Federation

State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer, Kazan, Tatarstan, Respublika 119992, Russian Federation

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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: March 2011
Last updated: December 10, 2014

Page last updated: August 23, 2015

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