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Post Herpetic NeuralgiaPhase 3NCT01270828

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

A Phase 3 study testing Pregabalin in people with Post Herpetic Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 146 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Herpetic Neuralgia
What is being tested?
Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
146 sitesin 17 countries
Study dates
Mar 2011to Nov 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

146 sites in 17 countries.

146 sites in 17 countries

United States82 sites

  • Radiant Research

    Akron, Ohio, 44311

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Dent Neurological Institute

    Amherst, New York, 14226

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Arlington Research Center, Inc.

    Arlington, Texas, 76011

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Lovelace Scientific Resources, Inc.

    Austin, Texas, 78758

  • QUEST Research Institute

    Bingham Farms, Michigan, 48025

  • Millennium Pain Center, LLC

    Bloomington, Illinois, 61701

  • Injury Care Medical Center

    Boise, Idaho, 83713

  • Boston Clinical Trials

    Boston, Massachusetts, 02135

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33472

  • Beacon Clinical Research

    Brockton, Massachusetts, 02301

  • SPRI Clinical Trials LLC

    Brooklyn, New York, 11235

  • Center for Clinical Research, Inc

    Carmichael, California, 95608

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina, 29412

  • (IP Shipping Address) Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Chicago Anesthesia Pain Specialists

    Chicago, Illinois, 60657

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Community Medical Providers

    Clovis, California, 93611

  • Sierra Medical Research

    Clovis, California, 93612

  • Inland Pain Medicine

    Colton, California, 92324

  • Radiant Research

    Dallas, Texas, 75231

  • Providence Health Partners-Center for Clinical Research

    Dayton, Ohio, 45439

  • Advanced Pain Care Clinic

    Evansville, Indiana, 47714

  • Clinical Research Advantage

    Evansville, Indiana, 47714

  • Global Scientific Innovations

    Evansville, Indiana, 47714

  • Clinical Physiology Associates

    Fort Myers, Florida, 33916

  • Fundamental Research

    Gulf Shores, Alabama, 36542

  • Health Care Family Rehab & Research Center

    Hialeah, Florida, 33012

  • The Center for Pharmaceutical Research, PC

    Kansas City, Missouri, 64114

  • Clinical Investigation Specialists, Inc.

    Kenosha, Wisconsin, 53142

  • Wells Institute for Health Awareness

    Kettering, Ohio, 45429

  • The Helm Center

    Laguna Hills, California, 92637

  • The Office of Dr. Stephen H. Miller, MD

    Las Vegas, Nevada, 89144

  • Lincoln Internal Medicine Associates

    Lincoln, Nebraska, 68516

  • Larry Watkins, M.D. (Private Practice)

    Little Rock, Arkansas, 72205

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Hearne Family Practice Clinic

    Little Rock, Arkansas, 72206

  • University of Southern California

    Los Angeles, California, 90033

  • USC IDS Pharmacy

    Los Angeles, California, 90089

  • Montana Medical Research Inc

    Missoula, Montana, 59808

  • Clinical Trials of America, Inc.

    Monroe, Louisiana, 71201

  • Medex Healthcare Research, Inc - Saint Louis

    New York, New York, 10036

  • North American Partners In Pain Management

    New York, New York, 11580

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Infinity Medical Research, Inc.

    North Dartmouth, Massachusetts, 02747

  • Translational Research Group, Inc

    North Hollywood, California, 91606

  • Laszlo Jozsef Mate, MD

    North Palm Beach, Florida, 33408

  • Family Care Specialists

    Ocala, Florida, 34471

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Mark A Fisher

    Oklahoma City, Oklahoma, 73112

  • Drug Shipment Only: Heartland Clinical Research, Inc.

    Omaha, Nebraska, 68134

  • Heartland Clinical Research, Inc.

    Omaha, Nebraska, 68134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85027

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607

  • George J. Rederich, M.D., Incorporated

    Redondo Beach, California, 90277

  • ClinRx Research, LLC

    Richardson, Texas, 75080

  • Integrated Research Group, Inc.

    Riverside, California, 92506

  • Comprehensive Pain care of South Florida

    Royal Palm Beach, Florida, 33411

  • Drug Shipmnent Only Aristotelis T. Laliotis, M.D. Integrated Research Center, Inc.

    San Diego, California, 92117

  • Integrated Research Center, Inc.

    San Diego, California, 92117

  • Center For Clinical Research, Inc.

    San Francisco, California, 94115

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Clinvest, A Division of Banyan Group, Inc

    Springfield, Missouri, 65807

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Comprehensive Clinical Development Inc.

    St. Petersburg, Florida, 33716

  • Neurology Clinical Research, Inc.

    Sunrise, Florida, 33351

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • Meridien Research

    Tampa, Florida, 33606

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Hillcrest Family Health Centers, Division of Clinical Research

    Waco, Texas, 76710

  • Foothills Pain Management Clinic, PS

    West Covina, California, 91790

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia8 sites

  • State Budgetary Educational Institution for higher Professional Training "Kazan State Medical Univer

    Kazan', Tatarstan, Respublika, 119992

  • Kazan State Medical University

    Kazan', Tatarstan, Respublika, 420064

  • GBUZ Nizhny Novgorod Regional Clinical Hospital N.A. Semashko

    Nizhny Novgorod, 603126

  • Clinic of Nervous Diseases M.I. Astvatsaturov

    Saint Petersburg, 194175

  • St. Petersburg State Healthcare Institution City Hospital # 40 Kurortnogo Administrativnogo Rajona

    Saint Petersburg, 197706

  • State Budgetary Educational Institution for Higher Professional Education

    Smolensk, 214018

  • State Budgetary Educational Institution for Higher Professional Education

    Smolensk, 214019

  • State Budgetary Health Institution of Yaroslavl region "Clinical hospital #10"

    Yaroslavl, Russian Federation, 150023

Other trials in Russia

Ukraine7 sites

  • Public Institution "Institute of Neurology, Psychiatry and Narcology of AMS of Ukraine"

    Kharkiv, 61068

  • Kyiv City Clinical Hospital #4

    Kyiv, 03110

  • Lviv NMU n.a. Danylo Galytskyy

    Lviv, 79013

  • Regional Municipal Dermatovenerologic Dispensary

    Lviv, 79013

  • Crimean Republican Institution "Clinical Dermatovenerologic Dispensary"

    Simferopol, 95006

  • Municipal Establishment "Vinnitsa Regional Psychoneurological Hospital n.a. O.I. Yushchenko"

    Vinnitsa, 21005

  • Municipal Establishment "City Clinical Hospital #2", Neurology Department

    Zaporizhzhya, 69068

Other trials in Ukraine

Bulgaria6 sites

  • DCC "St. Pantaleimon" OOD

    Pleven, 5800

  • MHAT-Pleven

    Pleven, 5800

  • MBALNP "Sveti Naum" EAD, Klinika po nervni bolesti za dvigatelni narushenia

    Sofia, 1113

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

    Sofia, 1202

  • MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya

    Sofia, 1407

  • Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia

    Sofia, 1431

Other trials in Bulgaria

Poland6 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80286

  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni

    Gdynia, Pomeranian Voivodeship, 81384

  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Katowicach

    Katowice, Silesian Voivodeship, 40040

  • Prof. dr hab. med. Leszek Szepanski Prywatna Praktyka Lekarska Gabinet Reumatologiczny

    Lublin, Lublin Voivodeship, 20022

  • "SYNEXUS POLSKA" Sp. z o.o. Oddzial w Warszawie

    Warsaw, Masovian Voivodeship, 01192

  • "SYNEXUS POLSKA" Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 50088

Other trials in Poland

India5 sites

  • Manipal Hospital

    Bangalore, Karnataka, 560 017

  • M. S. Ramaiah Medical College and Hospitals

    Bangalore, Karnataka, 560 054

  • Medanta Institute of Neurosciences

    Gurgaon, Haryana, 122 001

  • Mallikatta Neuro Centre

    Mangalore, Karnataka, 575002

  • Indraprastha Apollo Hospitals

    New Delhi, 110 076

Other trials in India

South Africa5 sites

  • Iatros International

    Bloemfontein, 9301

  • Synapta Clinical Research Centre

    Durban, 4001

  • Mzansi Ethical Research Centre

    Middelburg, 1050

  • Nelson Mandela Academic Hospital Research Unit

    Mthatha, Eastern Cape, 5099

  • Jakaranda Pain Clinic

    Pretoria, 0014

Other trials in South Africa

Sweden5 sites

  • Me3plus Clinical Trials

    Gothenburg, 412 63

  • CTC, Sahlgrenska sjukhuset/SU

    Gothenburg, 413 45

  • Probare

    Lund, Skåne County, 222 22

  • Center for Lakemedelsstudier

    Malmö, 211 52

  • Bragee Medect AB

    Stockholm, 115 22

Other trials in Sweden

Slovakia4 sites

  • Euro-Neuro s.r.o., Neurologicka ambulancia

    Bratislava, 831 03

  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda, Neurologicke oddelenie

    Bratislava, 851 07

  • MUDr. Eva Gasparova - neurologicka ambulancia

    Hlohovec, 920 01

  • Neurologicka ambulancia, Neuron-DT,s.r.o.

    Žilina, 01001

Other trials in Slovakia

Colombia3 sites

  • Centro de Investigacion y Atencion Para la Salud Mental S.A. - CESAME

    Bogota, Cundinamarca, 0

  • Fundacion Cardiovascular de Colombia

    Floridablanca, Santander Department, 0

  • Reumalab S.A.S

    Medellín, Antioquia

Other trials in Colombia

Croatia3 sites

  • Opca bolnica Karlovac

    Karlovac, Karlovacka Županija, 47000

  • Klinicki Bolnicki Centar Osijek

    Osijek, Osjecko-baranjska Županija, 31000

  • Opca bolnica "Dr. Ivo Pedisic"

    Sisak, Sisacko-moslavacka Županija, 44000

Other trials in Croatia

Germany3 sites

  • DGS-Schmerzzentrum Eichstätt

    Eichstätt, 85072

  • Schmerzzentrum Frankfurt

    Frankfurt am Main, Hesse, 60311

  • pro scientia med im MARE Klinikum

    Kiel-Kronshagen, Schleswig-Holstein, 24119

Other trials in Germany

Denmark2 sites

  • Aalborg Sygehus Nord

    Aalborg, North Denmark, DK-900

  • Glostrup Hospital

    Glostrup Municipality, DK-2066

Other trials in Denmark

Hong Kong2 sites

  • Family Medicine

    Hong Kong

  • Queen Elizabeth Hospital

    Kowloon

Other trials in Hong Kong

Serbia2 sites

  • Clinic for Neurology

    Belgrade, 11000

  • Clinic for Neurology

    Niš, 18000

Other trials in Serbia

Taiwan2 sites

  • Chang Gung Medical Foundation-Linkou Branch

    Kwei Shan Town, Taoyuan County, 333

  • National Taiwan University Hospital (Neurology)

    Taipei, 100

Other trials in Taiwan

Czechia1 site

  • Neurologicka ambulance

    Prerov I, 750 02

Other trials in Czechia

About this study

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)

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)

Being tested
Pregabalin, placebo
Keywords
Control Release Pregabalin in Post Herpetic Neuralgia
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PregabalinDrug

    Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks

  • placeboDrug

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

Study groups in NCT01270828
Study groupRoleWhat they receive
Pregablain CR tablet 82.5 to 660mgExperimentalNot described
Receives: Drug: Pregabalin
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 13 Weeks

Secondary outcomes (16)

  1. 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:

    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.

    Measured: 13 Weeks

  2. 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.

    Measured: 13 Weeks

  3. 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.

    Measured: 13 Weeks

  4. 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

    Measured: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

  5. 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.

    Measured: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

  6. 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.

    Measured: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

  7. 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.

    Measured: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

  8. 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.

    Measured: Week 6 and Week 19

  9. 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.

    Measured: Week 19

  10. 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.

    Measured: Week 19

  11. 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.

    Measured: Week 19

  12. 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

    Measured: Week 19

  13. 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).

    Measured: Week 19

  14. 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.

    Measured: Week 19

  15. 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.

    Measured: Baseline to Week 20

  16. 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.

    Measured: Baseline, Weeks 6, 11, 15, 19 and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01270828
Sponsor's protocol ID
A0081224
Other IDs
2009-016766-86, 2009
Status last verified
Dec 2015
First submitted
4 Jan 2011
Last updated
28 Jan 2021
Data monitoring committee
Yes

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.

    PubMed 27753650

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin in people with Post Herpetic Neuralgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 146 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Russia, Ukraine, Bulgaria, Poland and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Loss of Therapeutic Response. (time frame: 13 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01270828, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.

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