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Neuropathic PainPhase 3NCT01701362

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

A Phase 3 study testing pregabalin in people with Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 156 sites in 13 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

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
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
542 participants
Where
156 sitesin 13 countries
Study dates
Oct 2012to Aug 2015
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

  • Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
  • Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
  • Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.

Who cannot join

  • Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
  • Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
  • Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
  • Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction [heart attack] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
  • Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
  • Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
  • Use of prohibited medications in the absence of appropriate washout periods.

Trial locations and contacts

156 sites in 13 countries.

156 sites in 13 countries

United States105 sites

  • Allegheny Pain Management, P.C.

    Altoona, Pennsylvania, 16602

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Integrated Neurology Services , PLLC

    Arlington, Virginia, 22205

  • IntegraTrials, LLC

    Arlington, Virginia, 22205

  • Advanced Rx Clinical Research

    Artesia, California, 90701

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Northern Ohio Neurosciences, LLC

    Bellevue, Ohio, 44811

  • Washington Center for Pain Management LLC

    Bellevue, Washington, 98004

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Colorado Clinic

    Boulder, Colorado, 80301

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33472

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina, 29412

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Rehabilitation Institute of Chicago

    Chicago, Illinois, 60611

  • Chicago Anesthesia Associates

    Chicago, Illinois, 60657

  • Advance Medical Research

    Clearwater, Florida, 33756

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • TLM Medical Services, LLC

    Columbia, South Carolina, 29204

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Dallas Pain Consultants

    Dallas, Texas, 75203

  • FutureSearch Trials of Dallas, L. P.

    Dallas, Texas, 75231

  • Mountain View Clinical Research Inc.

    Denver, Colorado, 80209

  • Otri-Med Corporation

    Edgewood, Kentucky, 41017

  • Washington Center for Pain Management LLC

    Edmonds, Washington, 98026

  • Washington Center for Pain Management LLC

    Everett, Washington, 98201

  • St. Luke's Medical Clinic

    Fort Collins, Colorado, 80525

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • Dedicated Clinical Research

    Goodyear, Arizona, 85395

  • Piedmont Comprehensive Pain Management Group, LLC

    Greenville, South Carolina, 29601

  • Pharmacum Biomedical Research

    Greenville, South Carolina, 29605

  • Aga Clinical Trials

    Hialeah, Florida, 33012

  • Health Care Family Rehab & Research Center

    Hialeah, Florida, 33012

  • Research in Miami, Inc.

    Hialeah, Florida, 33013

  • Homestead Medical Research , Inc.

    Homestead, Florida, 33030

  • Abigail R. Neiman, MD, PA

    Houston, Texas, 77024

  • Agadadash Kuliev, MD, PA

    Houston, Texas, 77043

  • Biopharma Informatic Inc. Research Center

    Houston, Texas, 77043

  • Medstar Clinical Research Associates

    Houston, Texas, 77083

  • Tennesse Valley Pain Consultants

    Huntsville, Alabama, 35801

  • NervePro Medical Corp.

    Irvine, California, 92618

  • University of California, Irvine

    Irvine, California, 92697

  • Wells Institute for Health Awareness

    Kettering, Ohio, 45429

  • New Phase Research and Development

    Knoxville, Tennessee, 37919

  • Clinical and Translational Research Institute

    La Jolla, California, 92093

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • South Orange County Surgical Medical Group

    Laguna Hills, California, 92653

  • Centex Studies, Inc

    Lake Charles, Louisiana, 70601

  • Center For United Research, Inc.

    Lakewood, California, 90805

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • University of Southern California

    Los Angeles, California, 90033

  • USC I.D.S. Pharmacy

    Los Angeles, California, 90089

  • Samaritan Center for Medical Research

    Los Gatos, California, 95032

  • Georgia Institute for Clinical Research, LLC

    Marietta, Georgia, 30060

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33015

  • Advanced Pharma CR, LLC

    Miami, Florida, 33136

  • Florida International Research Center

    Miami, Florida, 33173

  • Kendall South Medical Center, Inc.

    Miami, Florida, 33185

  • AMPM Research Clinic

    Miami Gardens, Florida, 33169

  • North County Clinical Research

    Oceanside, California, 92056

  • Cor Clinical Research, Llc

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Heartland Clinical Research, Inc.

    Omaha, Nebraska, 68134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • A-One Family Practice

    Ormond Beach, Florida, 32174

  • Aba Family Medicine, LLC

    Ormond Beach, Florida, 32174

  • Ribo Research, LLC dba Peninsula Resarch

    Ormond Beach, Florida, 32174

  • Kansas City Bone & Joint Clinic

    Overland Park, Kansas, 66211

  • CRI Lifetree

    Philadelphia, Pennsylvania, 19139

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • The Pain Center of Arizona

    Phoenix, Arizona, 85027

  • Neuromuscular Research Center

    Phoenix, Arizona, 85028

  • Summit Research Network, Inc.

    Portland, Oregon, 97210

  • Washington Center for Pain Management LLC

    Renton, Washington, 98055

  • ClinRx Research, LLC

    Richardson, Texas, 75080

  • University of Rochester, Translational Pain Research

    Rochester, New York, 14618

  • Allied Clinical Research

    Roseville, California, 95661

  • Comprehensive Pain Care of South Florida

    Royal Palm Beach, Florida, 33411

  • Northern California Research

    Sacramento, California, 95821

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • J. Lewis Research, Inc./Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewish Research, Inc./Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • DCT - Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas, 78258

  • Sarasota Pain Medicine Research

    Sarasota, Florida, 34238

  • Sealy Urgent Care Center and Medical Clinic

    Sealy, Texas, 77474

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Advanced Internal Medicine, PC

    Stockbridge, Georgia, 30281

  • Research 1 Clinical Research Network, Inc. (Administrative Office Only)

    Stockbridge, Georgia, 30281

  • Meridien Research

    Tampa, Florida, 33634

  • Northwest Ohio Research Center, LLC

    Toledo, Ohio, 43623

  • Robert L Kalb, M.D, Inc

    Toledo, Ohio, 43623

  • Quality of Life Medical & Research Centers, LLC

    Tucson, Arizona, 85712

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Investigational Drug Services, The George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • The George Washington University Medical Center (Department of Neurology)

    Washington D.C., District of Columbia, 20037

  • The George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • Elite Clinical Trials, Inc.

    Wildomar, California, 92595

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany12 sites

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Synexus Clinical Research GmbH

    Bochum, 44787

  • Praxis für Spezielle Schmerztherapie und Palliativmedizin

    Böhlen, Saxony, 04564

  • Synexus Clinical Research GmbH

    Frankfurt, 60596

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Gemeinschaftspraxis für Schmerz- und Psychotherapie

    Hamburg, 22767

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, Lower Saxony, 30159

  • pro scientia med im MARE Klinikum

    Kiel-Kronshagen, Schleswig-Holstein, 24119

  • medamed GmbH Studienambulanz

    Leipzig, Saxony, 04109

  • Synexus Clinical Research GmbH

    Leipzig, 04103

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

Other trials in Germany

Poland7 sites

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

    Gdansk, 80-286

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

    Gdynia, 81-384

  • "Synexus Polska" Sp. z o.o. Oddzial W Katowicach

    Katowice, 40-040

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • NZOZ IGNIS dr n. med. Alicja Lobinska

    Świdnik, 21-040

  • "SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE

    Warsaw, 01-192

  • "SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu

    Wroclaw, 50-088

Other trials in Poland

Bulgaria6 sites

  • MHAT Puls AD

    Blagoevgrad, 2700

  • MHAT "Avis Medika"

    Pleven, 5800

  • MHAT "Sv.Pantaleymon"

    Pleven, 5800

  • DCC Akta Medika Ltd.

    Sevlievo, 5400

  • UMHAT Aleksandrovska

    Sofia, 1431

  • DCC "Sveta Anna"EOOD

    Sofia, 1709

Other trials in Bulgaria

Romania6 sites

  • Centrul Medical Sana

    Bucharest, 011025

  • Clubul Sanatatii SRL

    Campulung Muscel, 115100

  • Spitalul Clinic de Neuropsihiatrie Craiova

    Craiova, 200473

  • Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I

    Oradea, 410154

  • Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie

    Sibiu, 550166

  • Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II

    Târgu Mureş, 540136

Other trials in Romania

Sweden5 sites

  • Ladulaas Kliniken

    Borås, 506 30

  • CTC, Gothia Forum, Sahlgrenska Universitetssjukhus

    Gothenburg, 413 45

  • Probare

    Lund, 222 22

  • Pharmasite

    Malmö, 211 52

  • Bragee Medect AB

    Stockholm, 115 26

Other trials in Sweden

Canada4 sites

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • NRK Medical Research Clinic (Adminstrative Office Only)

    London, Ontario, N6H 4P2

  • NRK Medical Research Clinic

    London, Ontario, N6H 4P2

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3

Other trials in Canada

South Africa4 sites

  • Synexus SA - Stanza Clinical Research Centre

    Pretoria, Gauteng, 0122

  • Synexus SA - Watermeyer Clinical Research Centre

    Pretoria, Gauteng, 0184

  • Synexus SA - Roodepoort Medicross Clinical Research Centre

    Roodeport, Gauteng, 1724

  • Welkom Clinical Trial Centre

    Welkom, Free State, 9460

Other trials in South Africa

Hungary3 sites

  • Synexus Magyarorszag Kft.

    Budapest, 1036

  • UNO Medical Trials Kft

    Budapest, 1135

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

Other trials in Hungary

Croatia1 site

  • General Hospital "dr. Ivo Pedisic"

    Sisak, 44000

Other trials in Croatia

Denmark1 site

  • Glostrup Hospital

    Glostrup Municipality, 2600

Other trials in Denmark

Puerto Rico1 site

  • Ponce School of Medicine, CAIMED Center

    Ponce, 00716

Other trials in Puerto Rico

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.

Being tested
pregabalin, placebo
Keywords
post-traumatic peripheral neuropathic pain
Medical subject headings
Neuralgia

What participants receive

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

  • pregabalinDrug

    Also called Lyrica, PD-144723

    capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization

  • placeboDrug

    capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization

Study groups in NCT01701362
Study groupRoleWhat they receive
pregabalinActive comparatorNot 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. Baseline Mean Pain Score

    This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

    Measured: Baseline

  2. Change From Baseline to Week 15 in Weekly Mean Pain Score

    This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

    Measured: up to Week 15

Secondary outcomes (10)

  1. Patient Global Impression of Change (PGIC) at Week 15

    A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.

    Measured: Week 15

  2. Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)

    This is an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.

    Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.

    "Overall" is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.

    Measured: up to Week 15

  3. Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])

    A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.

    Measured: Week 15

  4. Change From Baseline in Pain Interference Index (BPI-sf)

    BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.

    It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).

    The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.

    Measured: Week 15

  5. Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores

    A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.

    Measured: Week 15

  6. Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.

    MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.

    Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.

    Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.

    Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.

    Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.

    Measured: Baseline

  7. Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.

    MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.

    Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.

    Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.

    Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.

    Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.

    Measured: Week 15

  8. Percentage of Participants in MOS-SS With Optimal Sleep Status.

    MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.

    Measured: Week 15

  9. Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.

    Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.

    Measured: Week 15

  10. Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%

    Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.

    Measured: Week 15

Timeline

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

  1. First posted5 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionAug 2015
  4. Study completionAug 2015

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
542 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701362
Sponsor's protocol ID
A0081279
Other IDs
2012-003304-12
Status last verified
Apr 2017
First submitted
3 Oct 2012
Last updated
28 Jan 2021
Data monitoring committee
Yes

Publications

  • Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21.

    PubMed 30242745

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin in people with Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 156 sites in 13 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 3 inclusion and 7 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 156 sites in United States, Germany, Poland, Bulgaria, Romania and 8 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 7 Jun 2017). 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?

Baseline Mean Pain Score (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT01701362, 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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