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

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ClinicalTrials.gov Identifier: NCT01270828
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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)

Condition or disease Intervention/treatment Phase
Post Herpetic Neuralgia Drug: Pregabalin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregablain CR tablet 82.5 to 660mg Drug: Pregabalin
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks

Placebo Comparator: Placebo Drug: placebo
Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks




Primary Outcome Measures :
  1. Number of Participants With Loss of Therapeutic Response. [ Time Frame: 13 Weeks ]
    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.


Secondary Outcome Measures :
  1. Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results [ Time Frame: 13 Weeks ]

    A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:

    1. At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score
    2. A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.

  2. Percentage of Participants With 30% Reduction in the Mean Pain Score. [ Time Frame: 13 Weeks ]
    The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.

  3. Percentage of Participants With 50% Reduction in the Mean Pain Score. [ Time Frame: 13 Weeks ]
    The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.

  4. Change From Baseline to Endpoint in Weekly Mean Pain Score. [ Time Frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]
    The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain

  5. Change in the Weekly NRS-Pain (1-Week Recall). [ Time Frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]
    The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.

  6. Change in the Medical Outcomes Study-Sleep Scale (MOS-SS). [ Time Frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]
    The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

  7. Change in the MOS-SS-Quantity of Sleep. [ Time Frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]

    The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.

    The item "Quantity of sleep" of MOS-SS is presented here.


  8. The MOS-SS-Optimal Sleep. [ Time Frame: Week 6 and Week 19 ]

    The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.

    The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The "percentage of participants with optimal sleep" is presented here.


  9. Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 19 ]
    The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.

  10. Change in the Short Form 36 Health Survey (SF-36) [ Time Frame: Week 19 ]
    The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.

  11. Change in Mean Daily Sleep Interference Scores [ Time Frame: Week 19 ]
    The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.

  12. Change in Hospital Anxiety and Depression Scales (HADS) [ Time Frame: Week 19 ]
    The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety

  13. Change in the Brief Pain Inventory (BPI-sf) [ Time Frame: Week 19 ]
    The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).

  14. Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW) [ Time Frame: Week 19 ]
    The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.

  15. Number of Participants With Adverse Events [ Time Frame: Baseline to Week 20 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective "severe" to those AEs that interfere significantly with participant's usual function.

  16. Percentage of Participants With Suicidal Behaviour/Ideation [ Time Frame: Baseline, Weeks 6, 11, 15, 19 and 20 ]
    Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270828


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United States, Alabama
Fundamental Research
Gulf Shores, Alabama, United States, 36542
United States, Arizona
Radiant Research, Inc.
Chandler, Arizona, United States, 85224
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
HOPE Research Institute
Phoenix, Arizona, United States, 85018
The Pain Center of Arizona
Phoenix, Arizona, United States, 85018
The Pain Center of Arizona
Phoenix, Arizona, United States, 85027
Genova Clinical Research
Tucson, Arizona, United States, 85704
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Larry Watkins, M.D. (Private Practice)
Little Rock, Arkansas, United States, 72205
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
Hearne Family Practice Clinic
Little Rock, Arkansas, United States, 72206
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Center for Clinical Research, Inc
Carmichael, California, United States, 95608
Community Medical Providers
Clovis, California, United States, 93611
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Clovis, California, United States, 93612
Inland Pain Medicine
Colton, California, United States, 92324
The Helm Center
Laguna Hills, California, United States, 92637
University of Southern California
Los Angeles, California, United States, 90033
USC IDS Pharmacy
Los Angeles, California, United States, 90089
Translational Research Group, Inc
North Hollywood, California, United States, 91606
George J. Rederich, M.D., Incorporated
Redondo Beach, California, United States, 90277
Integrated Research Group, Inc.
Riverside, California, United States, 92506
Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
San Diego, California, United States, 92117
Integrated Research Center, Inc.
San Diego, California, United States, 92117
Center For Clinical Research, Inc.
San Francisco, California, United States, 94115
Neurological Research Institute
Santa Monica, California, United States, 90404
Foothills Pain Management Clinic, PS
West Covina, California, United States, 91790
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JEM Research Institute
Atlantis, Florida, United States, 33462
Orthopedic Research Institute
Boynton Beach, Florida, United States, 33472
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Clearwater, Florida, United States, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States, 33765
Clinical Physiology Associates
Fort Myers, Florida, United States, 33916
Health Care Family Rehab & Research Center
Hialeah, Florida, United States, 33012
Laszlo Jozsef Mate, MD
North Palm Beach, Florida, United States, 33408
Family Care Specialists
Ocala, Florida, United States, 34471
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, LLC
Orlando, Florida, United States, 32806
Comprehensive Pain care of South Florida
Royal Palm Beach, Florida, United States, 33411
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St. Petersburg, Florida, United States, 33716
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Sunrise, Florida, United States, 33351
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Tampa, Florida, United States, 33603
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Injury Care Medical Center
Boise, Idaho, United States, 83713
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Millennium Pain Center, LLC
Bloomington, Illinois, United States, 61701
(IP Shipping Address) Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States, 60657
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Advanced Pain Care Clinic
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North Dartmouth, Massachusetts, United States, 02747
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Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
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Bingham Farms, Michigan, United States, 48025
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The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States, 64114
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Saint Louis, Missouri, United States, 63117
Clinvest, A Division of Banyan Group, Inc
Springfield, Missouri, United States, 65807
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Montana Medical Research Inc
Missoula, Montana, United States, 59808
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Lincoln Internal Medicine Associates
Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68134
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States, 68134
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Dent Neurological Institute
Amherst, New York, United States, 14226
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Brooklyn, New York, United States, 11235
Medex Healthcare Research, Inc - Saint Louis
New York, New York, United States, 10036
North American Partners In Pain Management
New York, New York, United States, 11580
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Asheville, North Carolina, United States, 28806
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Raleigh, North Carolina, United States, 27607
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Kettering, Ohio, United States, 45429
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Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
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Arlington, Texas, United States, 76011
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Austin, Texas, United States, 78758
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Richardson, Texas, United States, 75080
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Norfolk, Virginia, United States, 23507
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Kenosha, Wisconsin, United States, 53142
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DCC "St. Pantaleimon" OOD
Pleven, Bulgaria, 5800
MHAT-Pleven
Pleven, Bulgaria, 5800
MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
Sofia, Bulgaria, 1113
Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
Sofia, Bulgaria, 1202
MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
Sofia, Bulgaria, 1407
Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
Sofia, Bulgaria, 1431
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Reumalab S.A.S
Medellin, Antioquia, Colombia
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Bogota, Cundinamarca, Colombia, 0
Fundacion Cardiovascular de Colombia
Floridablanca, Santander, Colombia, 0
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Opca bolnica Karlovac
Karlovac, Karlovacka županija, Croatia, 47000
Klinicki Bolnicki Centar Osijek
Osijek, Osjecko-baranjska županija, Croatia, 31000
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Sisak, Sisacko-moslavacka županija, Croatia, 44000
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Neurologicka ambulance
Prerov I, Czech Republic, 750 02
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Aalborg Sygehus Nord
Aalborg, Region Nordjylland, Denmark, DK-900
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Glostrup, Denmark, DK-2066
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Schmerzzentrum Frankfurt
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pro scientia med im MARE Klinikum
Kiel-Kronshagen, Schleswig-Holstein, Germany, 24119
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Eichstaett, Germany, 85072
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Medanta Institute of Neurosciences
Gurgaon, Haryana, India, 122 001
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Bangalore, Karnataka, India, 560 017
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Bangalore, Karnataka, India, 560 054
Mallikatta Neuro Centre
Mangalore, Karnataka, India, 575002
Indraprastha Apollo Hospitals
New Delhi, India, 110 076
Poland
"SYNEXUS POLSKA" Sp. z o.o.
Wroclaw, Dolnoslaskie, Poland, 50088
Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
Lublin, Lubelskie, Poland, 20022
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie
Warszawa, Mazowieckie, Poland, 01192
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
Gdansk, Pomorskie, Poland, 80286
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomorskie, Poland, 81384
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach
Katowice, Slaskie, Poland, 40040
Russian Federation
State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
Kazan, Tatarstan, Respublika, Russian Federation, 119992
Kazan State Medical University
Kazan, Tatarstan, Respublika, Russian Federation, 420064
GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
Nizhny Novgorod, Russian Federation, 603126
Clinic of Nervous Diseases M.I. Astvatsaturov
Saint-Petersburg, Russian Federation, 194175
St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
Saint-Petersburg, Russian Federation, 197706
State Budgetary Educational Institution for Higher Professional Education
Smolensk, Russian Federation, 214018
State Budgetary Educational Institution for Higher Professional Education
Smolensk, Russian Federation, 214019
State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
Yaroslavl, Russian Federation, 150023
Serbia
Clinic for Neurology
Belgrade, Serbia, 11000
Clinic for Neurology
Nis, Serbia, 18000
Slovakia
Euro-Neuro s.r.o., Neurologicka ambulancia
Bratislava, Slovakia, 831 03
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
Bratislava, Slovakia, 851 07
MUDr. Eva Gasparova - neurologicka ambulancia
Hlohovec, Slovakia, 920 01
Neurologicka ambulancia, Neuron-DT,s.r.o.
Zilina, Slovakia, 01001
South Africa
Nelson Mandela Academic Hospital Research Unit
Mthatha, Eastern Cape, South Africa, 5099
Iatros International
Bloemfontein, South Africa, 9301
Synapta Clinical Research Centre
Durban, South Africa, 4001
Mzansi Ethical Research Centre
Middelburg, South Africa, 1050
Jakaranda Pain Clinic
Pretoria, South Africa, 0014
Sweden
Probare
Lund, Skane lan, Sweden, 222 22
Me3plus Clinical Trials
Goteborg, Sweden, 412 63
CTC, Sahlgrenska sjukhuset/SU
Goteborg, Sweden, 413 45
Center for Lakemedelsstudier
Malmo, Sweden, 211 52
Bragee Medect AB
Stockholm, Sweden, 115 22
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Kwei Shan Town, Taoyuan County, Taiwan, 333
National Taiwan University Hospital (Neurology)
Taipei, Taiwan, 100
Ukraine
Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
Kharkiv, Ukraine, 61068
Kyiv City Clinical Hospital #4
Kyiv, Ukraine, 03110
Lviv NMU n.a. Danylo Galytskyy
Lviv, Ukraine, 79013
Regional Municipal Dermatovenerologic Dispensary
Lviv, Ukraine, 79013
Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
Simferopol, Ukraine, 95006
Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
Vinnitsa, Ukraine, 21005
Municipal Establishment "City Clinical Hospital #2", Neurology Department
Zaporizhzhya, Ukraine, 69068
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270828     History of Changes
Other Study ID Numbers: A0081224
2009-016766-86 ( EudraCT Number )
First Posted: January 5, 2011    Key Record Dates
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016
Last Verified: December 2015

Keywords provided by Pfizer:
Control Release Pregabalin in Post Herpetic Neuralgia

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs