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)

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)

Study Overview

• Status: Completed
• Conditions: Post Herpetic Neuralgia
• Intervention / Treatment: Drug: Pregabalin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 806
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • DCC "St. Pantaleimon" OOD
  • Pleven, Bulgaria, 5800
    • MHAT-Pleven
  • Sofia, Bulgaria, 1407
    • MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
  • Sofia, Bulgaria, 1431
    • Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
  • Sofia, Bulgaria, 1113
    • MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
  • Sofia, Bulgaria, 1202
    • Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Reumalab S.A.S
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME
  • Santander
    • Floridablanca, Santander, Colombia
      • Fundacion Cardiovascular de Colombia
• Croatia
  • Karlovacka Županija
    • Karlovac, Karlovacka Županija, Croatia, 47000
      • Opca bolnica Karlovac
  • Osjecko-baranjska Županija
    • Osijek, Osjecko-baranjska Županija, Croatia, 31000
      • Klinicki bolnicki centar Osijek
  • Sisacko-moslavacka Županija
    • Sisak, Sisacko-moslavacka Županija, Croatia, 44000
      • Opca bolnica "Dr. Ivo Pedisic"
• Czechia
  • Prerov I, Czechia, 750 02
    • Neurologicka ambulance
• Denmark
  • Glostrup, Denmark, DK-2066
    • Glostrup Hospital
  • Region Nordjylland
    • Aalborg, Region Nordjylland, Denmark, DK-900
      • Aalborg Sygehus Nord
• Germany
  • Eichstaett, Germany, 85072
    • DGS-Schmerzzentrum Eichstätt
  • Hessen
    • Frankfurt/Main, Hessen, Germany, 60311
      • Schmerzzentrum Frankfurt
  • Schleswig-Holstein
    • Kiel-Kronshagen, Schleswig-Holstein, Germany, 24119
      • pro scientia med im MARE Klinikum
• Hong Kong
  • Hong Kong, Hong Kong
    • Family Medicine
  • Kowloon, Hong Kong
    • Queen Elizabeth Hospital
• India
  • New Delhi, India, 110 076
    • Indraprastha Apollo Hospitals
  • Haryana
    • Gurgaon, Haryana, India, 122 001
      • Medanta Institute of Neurosciences
  • Karnataka
    • Bangalore, Karnataka, India, 560 017
      • Manipal Hospital
    • Bangalore, Karnataka, India, 560 054
      • M. S. Ramaiah Medical College and Hospitals
    • Mangalore, Karnataka, India, 575002
      • Mallikatta Neuro Centre
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50088
      • "SYNEXUS POLSKA" Sp. z o.o.
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20022
      • Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01192
      • "SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80286
      • Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
    • Gdynia, Pomorskie, Poland, 81384
      • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
  • Slaskie
    • Katowice, Slaskie, Poland, 40040
      • "Synexus Polska" Sp. z o.o. Oddzial W Katowicach
• Russian Federation
  • Nizhny Novgorod, Russian Federation, 603126
    • GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
  • Saint-Petersburg, Russian Federation, 194175
    • Clinic of Nervous Diseases M.I. Astvatsaturov
  • Saint-Petersburg, Russian Federation, 197706
    • St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
  • Smolensk, Russian Federation, 214018
    • State Budgetary Educational Institution for Higher Professional Education
  • Smolensk, Russian Federation, 214019
    • State Budgetary Educational Institution for Higher Professional Education
  • Yaroslavl, Russian Federation, 150023
    • State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 119992
      • State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
    • Kazan, Tatarstan, Respublika, Russian Federation, 420064
      • Kazan State Medical University
• Serbia
  • Belgrade, Serbia, 11000
    • Clinic for Neurology
  • Nis, Serbia, 18000
    • Clinic for Neurology
• Slovakia
  • Bratislava, Slovakia, 831 03
    • Euro-Neuro s.r.o., Neurologicka ambulancia
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
  • Hlohovec, Slovakia, 920 01
    • MUDr. Eva Gasparova - neurologicka ambulancia
  • Zilina, Slovakia, 01001
    • Neurologicka ambulancia, Neuron-DT,s.r.o.
• South Africa
  • Bloemfontein, South Africa, 9301
    • Iatros International
  • Durban, South Africa, 4001
    • Synapta Clinical Research Centre
  • Middelburg, South Africa, 1050
    • Mzansi Ethical Research Centre
  • Pretoria, South Africa, 0014
    • Jakaranda Pain Clinic
  • Eastern Cape
    • Mthatha, Eastern Cape, South Africa, 5099
      • Nelson Mandela Academic Hospital Research Unit
• Sweden
  • Goteborg, Sweden, 413 45
    • CTC, Sahlgrenska sjukhuset/SU
  • Goteborg, Sweden, 412 63
    • ME3PLUS Clinical Trials
  • Malmo, Sweden, 211 52
    • Center for Lakemedelsstudier
  • Stockholm, Sweden, 115 22
    • Bragee Medect AB
  • Skane Lan
    • Lund, Skane Lan, Sweden, 222 22
      • ProbarE
• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital (Neurology)
  • Taoyuan County
    • Kwei Shan Town, Taoyuan County, Taiwan, 333
      • Chang Gung Medical Foundation-Linkou Branch
• Ukraine
  • Kharkiv, Ukraine, 61068
    • Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
  • Kyiv, Ukraine, 03110
    • Kyiv City Clinical Hospital #4
  • Lviv, Ukraine, 79013
    • Lviv NMU n.a. Danylo Galytskyy
  • Lviv, Ukraine, 79013
    • Regional Municipal Dermatovenerologic Dispensary
  • Simferopol, Ukraine, 95006
    • Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
  • Vinnitsa, Ukraine, 21005
    • Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
  • Zaporizhzhya, Ukraine, 69068
    • Municipal Establishment "City Clinical Hospital #2", Neurology Department
• United States
  • Alabama
    • Gulf Shores, Alabama, United States, 36542
      • Fundamental Research
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Radiant Research, Inc.
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85018
      • The Pain Center of Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies, LLC
    • Phoenix, Arizona, United States, 85027
      • The Pain Center of Arizona
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
    • Little Rock, Arkansas, United States, 72205
      • Larry Watkins, M.D. (Private Practice)
    • Little Rock, Arkansas, United States, 72206
      • Hearne Family Practice Clinic
  • California
    • Carmichael, California, United States, 95608
      • Center for Clinical Research, INC
    • Clovis, California, United States, 93611
      • Community Medical Providers
    • Clovis, California, United States, 93612
      • Sierra Medical Research
    • Colton, California, United States, 92324
      • Inland Pain Medicine
    • Laguna Hills, California, United States, 92637
      • The Helm Center
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Los Angeles, California, United States, 90089
      • USC IDS Pharmacy
    • North Hollywood, California, United States, 91606
      • Translational Research Group, Inc
    • Redondo Beach, California, United States, 90277
      • George J. Rederich, M.D., Incorporated
    • Riverside, California, United States, 92506
      • Integrated Research Group, Inc.
    • San Diego, California, United States, 92117
      • Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
    • San Diego, California, United States, 92117
      • Integrated Research Center, Inc.
    • San Francisco, California, United States, 94115
      • Center for Clinical Research, Inc.
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • West Covina, California, United States, 91790
      • Foothills Pain Management Clinic, PS
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Boynton Beach, Florida, United States, 33472
      • Orthopedic Research Institute
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida, Inc.
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc.
    • Fort Myers, Florida, United States, 33916
      • Clinical Physiology Associates
    • Hialeah, Florida, United States, 33012
      • Health Care Family Rehab & Research Center
    • North Palm Beach, Florida, United States, 33408
      • Laszlo Jozsef Mate, MD
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocala, Florida, United States, 34471
      • Family Care Specialists
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Royal Palm Beach, Florida, United States, 33411
      • Comprehensive Pain Care of South Florida
    • Saint Petersburg, Florida, United States, 33716
      • Comprehensive Clinical Development Inc.
    • Sunrise, Florida, United States, 33351
      • Neurology Clinical Research, Inc.
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
    • Tampa, Florida, United States, 33606
      • Meridien Research
  • Idaho
    • Boise, Idaho, United States, 83713
      • Injury Care Medical Center
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Millennium Pain Center, LLC
    • Chicago, Illinois, United States, 60657
      • Chicago Anesthesia Pain Specialists
    • Chicago, Illinois, United States, 60657
      • (IP Shipping Address) Advocate Illinois Masonic Medical Center
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Clinical Research Advantage
    • Evansville, Indiana, United States, 47714
      • Global Scientific Innovations
    • Evansville, Indiana, United States, 47714
      • Advanced Pain Care Clinic
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Boston Clinical Trials
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain & Neurological Institute
    • Bingham Farms, Michigan, United States, 48025
      • Quest Research Institute
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research, PC
    • Saint Louis, Missouri, United States, 63117
      • Medex Healthcare Research, Inc.
    • Springfield, Missouri, United States, 65807
      • Clinvest, A Division of Banyan Group, Inc
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research Inc
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Lincoln Internal Medicine Associates
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68134
      • Drug Shipment Only: Heartland Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • The Office of Dr. Stephen H. Miller, MD
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurological Institute
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials LLC
    • New York, New York, United States, 10036
      • Medex Healthcare Research, Inc - Saint Louis
    • New York, New York, United States, 11580
      • North American Partners in Pain Management
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists, PA
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates, P.A.
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
    • Dayton, Ohio, United States, 45439
      • Providence Health Partners-Center for Clinical Research
    • Kettering, Ohio, United States, 45429
      • Wells Institute for Health Awareness
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • Mark A Fisher
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Pharmacorp Clinical Trials, Inc.
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Austin, Texas, United States, 78758
      • Lovelace Scientific Resources, Inc.
    • Dallas, Texas, United States, 75231
      • Radiant Research
    • Richardson, Texas, United States, 75080
      • ClinRx Research, LLC
    • Waco, Texas, United States, 76710
      • Hillcrest Family Health Centers, Division of Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Clinical Investigation Specialists, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo; Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
EXPERIMENTAL: Pregablain CR tablet 82.5 to 660mg	Drug: Pregabalin; Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results	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: At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score; 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.	13 Weeks
Percentage of Participants With 30% Reduction in the Mean Pain Score.	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.	13 Weeks
Percentage of Participants With 50% Reduction in the Mean Pain Score.	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.	13 Weeks
Change From Baseline to Endpoint in Weekly Mean Pain Score.	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	SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Change in the Weekly NRS-Pain (1-Week Recall).	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.	SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).	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.	SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Change in the MOS-SS-Quantity of Sleep.	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.	SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
The MOS-SS-Optimal Sleep.	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.	Week 6 and Week 19
Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score	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.	Week 19
Change in the Short Form 36 Health Survey (SF-36)	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.	Week 19
Change in Mean Daily Sleep Interference Scores	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.	Week 19
Change in Hospital Anxiety and Depression Scales (HADS)	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	Week 19
Change in the Brief Pain Inventory (BPI-sf)	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).	Week 19
Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)	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.	Week 19
Number of Participants With Adverse Events	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.	Baseline to Week 20
Percentage of Participants With Suicidal Behaviour/Ideation	Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.	Baseline, Weeks 6, 11, 15, 19 and 20

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (ESTIMATE): January 5, 2011

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Control Release Pregabalin in Post Herpetic Neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081224; 2009-016766-86 (EUDRACT_NUMBER)