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

Primary Purpose

Post Herpetic Neuralgia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring Control Release Pregabalin in Post Herpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundamental Research
  • Radiant Research, Inc.
  • Elite Clinical Studies, LLC
  • HOPE Research Institute
  • The Pain Center of Arizona
  • The Pain Center of Arizona
  • Genova Clinical Research
  • Larry Watkins, M.D. (Private Practice)
  • Lynn Institute of the Ozarks
  • Hearne Family Practice Clinic
  • Center for Clinical Research, Inc
  • Community Medical Providers
  • Sierra Medical Research
  • Inland Pain Medicine
  • The Helm Center
  • University of Southern California
  • USC IDS Pharmacy
  • Translational Research Group, Inc
  • George J. Rederich, M.D., Incorporated
  • Integrated Research Group, Inc.
  • Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
  • Integrated Research Center, Inc.
  • Center For Clinical Research, Inc.
  • Neurological Research Institute
  • Foothills Pain Management Clinic, PS
  • JEM Research Institute
  • Orthopedic Research Institute
  • Innovative Research of West Florida, Inc.
  • Clinical Research of West Florida, Inc.
  • Clinical Physiology Associates
  • Health Care Family Rehab & Research Center
  • Laszlo Jozsef Mate, MD
  • Family Care Specialists
  • Renstar Medical Research
  • Compass Research, LLC
  • Comprehensive Pain care of South Florida
  • Comprehensive Clinical Development Inc.
  • Neurology Clinical Research, Inc.
  • Clinical Research of West Florida, Inc.
  • Meridien Research
  • Injury Care Medical Center
  • Millennium Pain Center, LLC
  • (IP Shipping Address) Advocate Illinois Masonic Medical Center
  • Chicago Anesthesia Pain Specialists
  • Advanced Pain Care Clinic
  • Clinical Research Advantage
  • Global Scientific Innovations
  • Clinical Trials of America, Inc.
  • Boston Clinical Trials
  • Beacon Clinical Research
  • Infinity Medical Research, Inc.
  • Michigan Head Pain & Neurological Institute
  • QUEST Research Institute
  • The Center for Pharmaceutical Research, PC
  • Medex Healthcare Research, Inc.
  • Clinvest, A Division of Banyan Group, Inc
  • Montana Medical Research Inc
  • Lincoln Internal Medicine Associates
  • Drug Shipment Only: Heartland Clinical Research, Inc.
  • Heartland Clinical Research, Inc.
  • The Office of Dr. Stephen H. Miller, MD
  • Albuquerque Clinical Trials, Inc.
  • Dent Neurological Institute
  • SPRI Clinical Trials LLC
  • Medex Healthcare Research, Inc - Saint Louis
  • North American Partners In Pain Management
  • Asheville Neurology Specialists, PA
  • Raleigh Neurology Associates, P.A.
  • The Center for Clinical Research
  • Radiant Research
  • Providence Health Partners-Center for Clinical Research
  • Wells Institute for Health Awareness
  • Lynn Health Science Institute
  • Mark A Fisher
  • Pharmacorp Clinical Trials, Inc.
  • Arlington Research Center, Inc.
  • Lovelace Scientific Resources, Inc.
  • Radiant Research
  • ClinRx Research, LLC
  • Hillcrest Family Health Centers, Division of Clinical Research
  • Clinical Research Associates of Tidewater
  • Clinical Investigation Specialists, Inc.
  • DCC "St. Pantaleimon" OOD
  • MHAT-Pleven
  • MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
  • Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
  • MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
  • Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
  • Reumalab S.A.S
  • Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME
  • Fundacion Cardiovascular de Colombia
  • Opca bolnica Karlovac
  • Klinicki Bolnicki Centar Osijek
  • Opca bolnica "Dr. Ivo Pedisic"
  • Neurologicka ambulance
  • Aalborg Sygehus Nord
  • Glostrup Hospital
  • Schmerzzentrum Frankfurt
  • pro scientia med im MARE Klinikum
  • DGS-Schmerzzentrum Eichstätt
  • Family Medicine
  • Queen Elizabeth Hospital
  • Medanta Institute of Neurosciences
  • Manipal Hospital
  • M. S. Ramaiah Medical College and Hospitals
  • Mallikatta Neuro Centre
  • Indraprastha Apollo Hospitals
  • "SYNEXUS POLSKA" Sp. z o.o.
  • Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie
  • Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach
  • State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
  • Kazan State Medical University
  • GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
  • Clinic of Nervous Diseases M.I. Astvatsaturov
  • St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
  • State Budgetary Educational Institution for Higher Professional Education
  • State Budgetary Educational Institution for Higher Professional Education
  • State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
  • Clinic for Neurology
  • Clinic for Neurology
  • Euro-Neuro s.r.o., Neurologicka ambulancia
  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
  • MUDr. Eva Gasparova - neurologicka ambulancia
  • Neurologicka ambulancia, Neuron-DT,s.r.o.
  • Nelson Mandela Academic Hospital Research Unit
  • Iatros International
  • Synapta Clinical Research Centre
  • Mzansi Ethical Research Centre
  • Jakaranda Pain Clinic
  • Probare
  • Me3plus Clinical Trials
  • CTC, Sahlgrenska sjukhuset/SU
  • Center for Lakemedelsstudier
  • Bragee Medect AB
  • Chang Gung Medical Foundation-Linkou Branch
  • National Taiwan University Hospital (Neurology)
  • Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
  • Kyiv City Clinical Hospital #4
  • Lviv NMU n.a. Danylo Galytskyy
  • Regional Municipal Dermatovenerologic Dispensary
  • Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
  • Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
  • Municipal Establishment "City Clinical Hospital #2", Neurology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregablain CR tablet 82.5 to 660mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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
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).
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.
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.
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.

Full Information

First Posted
January 4, 2011
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01270828
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia
Keywords
Control Release Pregabalin in Post Herpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregablain CR tablet 82.5 to 660mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Loss of Therapeutic Response.
Description
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.
Time Frame
13 Weeks
Secondary Outcome Measure Information:
Title
Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results
Description
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.
Time Frame
13 Weeks
Title
Percentage of Participants With 30% Reduction in the Mean Pain Score.
Description
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.
Time Frame
13 Weeks
Title
Percentage of Participants With 50% Reduction in the Mean Pain Score.
Description
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.
Time Frame
13 Weeks
Title
Change From Baseline to Endpoint in Weekly Mean Pain Score.
Description
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
Time Frame
SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Title
Change in the Weekly NRS-Pain (1-Week Recall).
Description
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.
Time Frame
SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Title
Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).
Description
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.
Time Frame
SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Title
Change in the MOS-SS-Quantity of Sleep.
Description
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.
Time Frame
SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
Title
The MOS-SS-Optimal Sleep.
Description
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.
Time Frame
Week 6 and Week 19
Title
Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score
Description
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.
Time Frame
Week 19
Title
Change in the Short Form 36 Health Survey (SF-36)
Description
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.
Time Frame
Week 19
Title
Change in Mean Daily Sleep Interference Scores
Description
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.
Time Frame
Week 19
Title
Change in Hospital Anxiety and Depression Scales (HADS)
Description
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
Time Frame
Week 19
Title
Change in the Brief Pain Inventory (BPI-sf)
Description
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).
Time Frame
Week 19
Title
Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)
Description
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.
Time Frame
Week 19
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
Baseline to Week 20
Title
Percentage of Participants With Suicidal Behaviour/Ideation
Description
Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.
Time Frame
Baseline, Weeks 6, 11, 15, 19 and 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Fundamental Research
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Larry Watkins, M.D. (Private Practice)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Hearne Family Practice Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72206
Country
United States
Facility Name
Center for Clinical Research, Inc
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Community Medical Providers
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
Sierra Medical Research
City
Clovis
State/Province
California
ZIP/Postal Code
93612
Country
United States
Facility Name
Inland Pain Medicine
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
The Helm Center
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92637
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC IDS Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Translational Research Group, Inc
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
George J. Rederich, M.D., Incorporated
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Integrated Research Group, Inc.
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Integrated Research Center, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Center For Clinical Research, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Foothills Pain Management Clinic, PS
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Health Care Family Rehab & Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Laszlo Jozsef Mate, MD
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Family Care Specialists
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Comprehensive Pain care of South Florida
City
Royal Palm Beach
State/Province
Florida
ZIP/Postal Code
33411
Country
United States
Facility Name
Comprehensive Clinical Development Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Neurology Clinical Research, Inc.
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Injury Care Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Millennium Pain Center, LLC
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
(IP Shipping Address) Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Chicago Anesthesia Pain Specialists
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Advanced Pain Care Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Clinical Research Advantage
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Global Scientific Innovations
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Beacon Clinical Research
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Infinity Medical Research, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Michigan Head Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
QUEST Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
The Center for Pharmaceutical Research, PC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Clinvest, A Division of Banyan Group, Inc
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Montana Medical Research Inc
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Lincoln Internal Medicine Associates
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Drug Shipment Only: Heartland Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Heartland Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
The Office of Dr. Stephen H. Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
SPRI Clinical Trials LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Medex Healthcare Research, Inc - Saint Louis
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
North American Partners In Pain Management
City
New York
State/Province
New York
ZIP/Postal Code
11580
Country
United States
Facility Name
Asheville Neurology Specialists, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Raleigh Neurology Associates, P.A.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Radiant Research
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Providence Health Partners-Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Wells Institute for Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Mark A Fisher
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Pharmacorp Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Arlington Research Center, Inc.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
ClinRx Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Hillcrest Family Health Centers, Division of Clinical Research
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
DCC "St. Pantaleimon" OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT-Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie ¿ Sofia, AD, Sofia, Nevrologichno otdelenie
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Reumalab S.A.S
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0
Country
Colombia
Facility Name
Fundacion Cardiovascular de Colombia
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
0
Country
Colombia
Facility Name
Opca bolnica Karlovac
City
Karlovac
State/Province
Karlovacka Županija
ZIP/Postal Code
47000
Country
Croatia
Facility Name
Klinicki Bolnicki Centar Osijek
City
Osijek
State/Province
Osjecko-baranjska Županija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Opca bolnica "Dr. Ivo Pedisic"
City
Sisak
State/Province
Sisacko-moslavacka Županija
ZIP/Postal Code
44000
Country
Croatia
Facility Name
Neurologicka ambulance
City
Prerov I
ZIP/Postal Code
750 02
Country
Czechia
Facility Name
Aalborg Sygehus Nord
City
Aalborg
State/Province
Region Nordjylland
ZIP/Postal Code
DK-900
Country
Denmark
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
DK-2066
Country
Denmark
Facility Name
Schmerzzentrum Frankfurt
City
Frankfurt/Main
State/Province
Hessen
ZIP/Postal Code
60311
Country
Germany
Facility Name
pro scientia med im MARE Klinikum
City
Kiel-Kronshagen
State/Province
Schleswig-Holstein
ZIP/Postal Code
24119
Country
Germany
Facility Name
DGS-Schmerzzentrum Eichstätt
City
Eichstaett
ZIP/Postal Code
85072
Country
Germany
Facility Name
Family Medicine
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Medanta Institute of Neurosciences
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122 001
Country
India
Facility Name
Manipal Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 017
Country
India
Facility Name
M. S. Ramaiah Medical College and Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Mallikatta Neuro Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575002
Country
India
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
ZIP/Postal Code
110 076
Country
India
Facility Name
"SYNEXUS POLSKA" Sp. z o.o.
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50088
Country
Poland
Facility Name
Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20022
Country
Poland
Facility Name
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01192
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80286
Country
Poland
Facility Name
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81384
Country
Poland
Facility Name
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40040
Country
Poland
Facility Name
State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Clinic of Nervous Diseases M.I. Astvatsaturov
City
Saint-Petersburg
ZIP/Postal Code
194175
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona
City
Saint-Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
State Budgetary Educational Institution for Higher Professional Education
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
State Budgetary Educational Institution for Higher Professional Education
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"
City
Yaroslavl
ZIP/Postal Code
150023
Country
Russian Federation
Facility Name
Clinic for Neurology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Neurology
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Euro-Neuro s.r.o., Neurologicka ambulancia
City
Bratislava
ZIP/Postal Code
831 03
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
MUDr. Eva Gasparova - neurologicka ambulancia
City
Hlohovec
ZIP/Postal Code
920 01
Country
Slovakia
Facility Name
Neurologicka ambulancia, Neuron-DT,s.r.o.
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Nelson Mandela Academic Hospital Research Unit
City
Mthatha
State/Province
Eastern Cape
ZIP/Postal Code
5099
Country
South Africa
Facility Name
Iatros International
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Synapta Clinical Research Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Mzansi Ethical Research Centre
City
Middelburg
ZIP/Postal Code
1050
Country
South Africa
Facility Name
Jakaranda Pain Clinic
City
Pretoria
ZIP/Postal Code
0014
Country
South Africa
Facility Name
Probare
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
Me3plus Clinical Trials
City
Goteborg
ZIP/Postal Code
412 63
Country
Sweden
Facility Name
CTC, Sahlgrenska sjukhuset/SU
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Center for Lakemedelsstudier
City
Malmo
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Bragee Medect AB
City
Stockholm
ZIP/Postal Code
115 22
Country
Sweden
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Kwei Shan Town
State/Province
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
National Taiwan University Hospital (Neurology)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #4
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Lviv NMU n.a. Danylo Galytskyy
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Regional Municipal Dermatovenerologic Dispensary
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"
City
Vinnitsa
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Establishment "City Clinical Hospital #2", Neurology Department
City
Zaporizhzhya
ZIP/Postal Code
69068
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
27753650
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081224&StudyName=Safety%20And%20Efficacy%20Study%20Of%20Once%20Daily%20Controlled%20Release%20Pregabalin%20In%20The%20Treatment%20Of%20Patients%20With%20Postherpetic%20Neuralgia%20
Description
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Learn more about this trial

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

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