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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01701362
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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, focal/localized burns or crush injury.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: pregabalin Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 542 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: pregabalin Drug: pregabalin
capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
Other Name: Lyrica, PD-144723

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




Primary Outcome Measures :
  1. Baseline Mean Pain Score [ Time Frame: Baseline ]
    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.

  2. Change From Baseline to Week 15 in Weekly Mean Pain Score [ Time Frame: up to Week 15 ]
    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.


Secondary Outcome Measures :
  1. Patient Global Impression of Change (PGIC) at Week 15 [ Time Frame: 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.

  2. Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) [ Time Frame: up to Week 15 ]

    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.


  3. Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf]) [ Time Frame: Week 15 ]
    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.

  4. Change From Baseline in Pain Interference Index (BPI-sf) [ Time Frame: Week 15 ]

    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.


  5. Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores [ Time Frame: Week 15 ]
    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.

  6. Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. [ Time Frame: Baseline ]

    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.


  7. Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. [ Time Frame: Week 15 ]

    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.


  8. Percentage of Participants in MOS-SS With Optimal Sleep Status. [ Time Frame: Week 15 ]
    MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.

  9. Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. [ Time Frame: Week 15 ]
    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.

  10. Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% [ Time Frame: Week 15 ]
    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.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701362


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Locations
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United States, Alabama
Tennesse Valley Pain Consultants
Huntsville, Alabama, United States, 35801
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018
HOPE Research Institute
Phoenix, Arizona, United States, 85018
The Pain Center of Arizona
Phoenix, Arizona, United States, 85018
Arizona Research Center
Phoenix, Arizona, United States, 85023
The Pain Center of Arizona
Phoenix, Arizona, United States, 85027
Neuromuscular Research Center
Phoenix, Arizona, United States, 85028
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, United States, 85712
United States, California
Advanced Rx Clinical Research
Artesia, California, United States, 90701
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
NervePro Medical Corp.
Irvine, California, United States, 92618
University of California, Irvine
Irvine, California, United States, 92697
Clinical and Translational Research Institute
La Jolla, California, United States, 92093
Alliance Research Centers
Laguna Hills, California, United States, 92653
South Orange County Surgical Medical Group
Laguna Hills, California, United States, 92653
Center For United Research, Inc.
Lakewood, California, United States, 90805
University of Southern California
Los Angeles, California, United States, 90033
USC I.D.S. Pharmacy
Los Angeles, California, United States, 90089
Samaritan Center for Medical Research
Los Gatos, California, United States, 95032
North County Clinical Research
Oceanside, California, United States, 92056
Allied Clinical Research
Roseville, California, United States, 95661
Northern California Research
Sacramento, California, United States, 95821
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Elite Clinical Trials, Inc.
Wildomar, California, United States, 92595
United States, Colorado
Colorado Clinic
Boulder, Colorado, United States, 80301
Mountain View Clinical Research Inc.
Denver, Colorado, United States, 80209
St. Luke's Medical Clinic
Fort Collins, Colorado, United States, 80525
United States, District of Columbia
Investigational Drug Services, The George Washington University Medical Center
Washington, D.C., District of Columbia, United States, 20037
The George Washington University Medical Center (Department of Neurology)
Washington, D.C., District of Columbia, United States, 20037
The George Washington University Medical Center
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
Orthopedic Research Institute
Boynton Beach, Florida, United States, 33472
Advance Medical Research
Clearwater, Florida, United States, 33756
Innovative Research of West Florida
Clearwater, Florida, United States, 33756
Aga Clinical Trials
Hialeah, Florida, United States, 33012
Health Care Family Rehab & Research Center
Hialeah, Florida, United States, 33012
Research in Miami, Inc.
Hialeah, Florida, United States, 33013
Homestead Medical Research , Inc.
Homestead, Florida, United States, 33030
AMPM Research Clinic
Miami Gardens, Florida, United States, 33169
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
Advanced Pharma CR, LLC
Miami, Florida, United States, 33136
Florida International Research Center
Miami, Florida, United States, 33173
Kendall South Medical Center, Inc.
Miami, Florida, United States, 33185
Compass Research, LLC
Orlando, Florida, United States, 32806
A-One Family Practice
Ormond Beach, Florida, United States, 32174
Aba Family Medicine, LLC
Ormond Beach, Florida, United States, 32174
Ribo Research, LLC dba Peninsula Resarch
Ormond Beach, Florida, United States, 32174
Comprehensive Pain Care of South Florida
Royal Palm Beach, Florida, United States, 33411
Sarasota Pain Medicine Research
Sarasota, Florida, United States, 34238
Meridien Research
Tampa, Florida, United States, 33634
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States, 30060
Advanced Internal Medicine, PC
Stockbridge, Georgia, United States, 30281
Research 1 Clinical Research Network, Inc. (Administrative Office Only)
Stockbridge, Georgia, United States, 30281
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Chicago Anesthesia Associates
Chicago, Illinois, United States, 60657
United States, Kansas
Kansas City Bone & Joint Clinic
Overland Park, Kansas, United States, 66211
United States, Kentucky
Otri-Med Corporation
Edgewood, Kentucky, United States, 41017
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
United States, Louisiana
Centex Studies, Inc
Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Medex Healthcare Research, Inc.
Saint Louis, Missouri, United States, 63117
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States, 68134
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New York
University of Rochester, Translational Pain Research
Rochester, New York, United States, 14618
United States, North Carolina
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Northern Ohio Neurosciences, LLC
Bellevue, Ohio, United States, 44811
Wells Institute for Health Awareness
Kettering, Ohio, United States, 45429
Northwest Ohio Research Center, LLC
Toledo, Ohio, United States, 43623
Robert L Kalb, M.D, Inc
Toledo, Ohio, United States, 43623
United States, Oklahoma
Cor Clinical Research, Llc
Oklahoma City, Oklahoma, United States, 73103
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Summit Research Network, Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Allegheny Pain Management, P.C.
Altoona, Pennsylvania, United States, 16602
CRI Lifetree
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, United States, 29412
TLM Medical Services, LLC
Columbia, South Carolina, United States, 29204
Piedmont Comprehensive Pain Management Group, LLC
Greenville, South Carolina, United States, 29601
Pharmacum Biomedical Research
Greenville, South Carolina, United States, 29605
United States, Tennessee
New Phase Research and Development
Knoxville, Tennessee, United States, 37919
United States, Texas
Dallas Pain Consultants
Dallas, Texas, United States, 75203
FutureSearch Trials of Dallas, L. P.
Dallas, Texas, United States, 75231
Abigail R. Neiman, MD, PA
Houston, Texas, United States, 77024
Agadadash Kuliev, MD, PA
Houston, Texas, United States, 77043
Biopharma Informatic Inc. Research Center
Houston, Texas, United States, 77043
Medstar Clinical Research Associates
Houston, Texas, United States, 77083
ClinRx Research, LLC
Richardson, Texas, United States, 75080
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States, 78258
Sealy Urgent Care Center and Medical Clinic
Sealy, Texas, United States, 77474
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States, 76309
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
J. Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
J. Lewish Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
United States, Virginia
Integrated Neurology Services , PLLC
Arlington, Virginia, United States, 22205
IntegraTrials, LLC
Arlington, Virginia, United States, 22205
United States, Washington
Washington Center for Pain Management LLC
Bellevue, Washington, United States, 98004
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Washington Center for Pain Management LLC
Edmonds, Washington, United States, 98026
Washington Center for Pain Management LLC
Everett, Washington, United States, 98201
Washington Center for Pain Management LLC
Renton, Washington, United States, 98055
Summit Research Network (Seattle) LLC
Seattle, Washington, United States, 98104
Bulgaria
MHAT Puls AD
Blagoevgrad, Bulgaria, 2700
MHAT "Avis Medika"
Pleven, Bulgaria, 5800
MHAT "Sv.Pantaleymon"
Pleven, Bulgaria, 5800
DCC Akta Medika Ltd.
Sevlievo, Bulgaria, 5400
UMHAT Aleksandrovska
Sofia, Bulgaria, 1431
DCC "Sveta Anna"EOOD
Sofia, Bulgaria, 1709
Canada, Ontario
Aggarwal and Associates Limited
Brampton, Ontario, Canada, L6T 0G1
NRK Medical Research Clinic (Adminstrative Office Only)
London, Ontario, Canada, N6H 4P2
NRK Medical Research Clinic
London, Ontario, Canada, N6H 4P2
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada, N7T 4X3
Croatia
General Hospital "dr. Ivo Pedisic"
Sisak, Croatia, 44000
Denmark
Glostrup Hospital
Glostrup, Denmark, 2600
Germany
Klinische Forschung Hannover-Mitte GmbH
Hannover, Niedersachsen, Germany, 30159
Praxis für Spezielle Schmerztherapie und Palliativmedizin
Böhlen, Sachsen, Germany, 04564
medamed GmbH Studienambulanz
Leipzig, Sachsen, Germany, 04109
pro scientia med im MARE Klinikum
Kiel-Kronshagen, Schleswig-holstein, Germany, 24119
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
Synexus Clinical Research GmbH
Berlin, Germany, 12627
Synexus Clinical Research GmbH
Bochum, Germany, 44787
Synexus Clinical Research GmbH
Frankfurt, Germany, 60596
Klinische Forschung Hamburg GmbH
Hamburg, Germany, 20253
Gemeinschaftspraxis für Schmerz- und Psychotherapie
Hamburg, Germany, 22767
Synexus Clinical Research GmbH
Leipzig, Germany, 04103
Klinische Forschung Schwerin GmbH
Schwerin, Germany, 19055
Hungary
Synexus Magyarorszag Kft.
Budapest, Hungary, 1036
UNO Medical Trials Kft
Budapest, Hungary, 1135
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Przychodnia Morena" Sp. z.o.o.
Gdansk, Poland, 80-286
"SYNEXUS POLSKA" Sp. z o.o. Oddzial w Gdyni
Gdynia, Poland, 81-384
"Synexus Polska" Sp. z o.o. Oddzial W Katowicach
Katowice, Poland, 40-040
Malopolskie Centrum Medyczne S.C.
Krakow, Poland, 30-510
NZOZ IGNIS dr n. med. Alicja Lobinska
Swidnik, Poland, 21-040
"SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
Warszawa, Poland, 01-192
"SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu
Wroclaw, Poland, 50-088
Puerto Rico
Ponce School of Medicine, CAIMED Center
Ponce, Puerto Rico, 00716
Romania
Centrul Medical Sana
Bucuresti, Romania, 011025
Clubul Sanatatii SRL
Campulung Muscel, Romania, 115100
Spitalul Clinic de Neuropsihiatrie Craiova
Craiova, Romania, 200473
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I
Oradea, Romania, 410154
Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie
Sibiu, Romania, 550166
Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II
Targu Mures, Romania, 540136
South Africa
Welkom Clinical Trial Centre
Welkom, Free State, South Africa, 9460
Synexus SA - Stanza Clinical Research Centre
Pretoria, Gauteng, South Africa, 0122
Synexus SA - Watermeyer Clinical Research Centre
Pretoria, Gauteng, South Africa, 0184
Synexus SA - Roodepoort Medicross Clinical Research Centre
Roodeport, Gauteng, South Africa, 1724
Sweden
Ladulaas Kliniken
Boras, Sweden, 506 30
CTC, Gothia Forum, Sahlgrenska Universitetssjukhus
Göteborg, Sweden, 413 45
Probare
Lund, Sweden, 222 22
Pharmasite
Malmö, Sweden, 211 52
Bragee Medect AB
Stockholm, Sweden, 115 26
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01701362     History of Changes
Other Study ID Numbers: A0081279
2012-003304-12 ( EudraCT Number )
First Posted: October 5, 2012    Key Record Dates
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: April 2017

Keywords provided by Pfizer:
post-traumatic peripheral neuropathic pain

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