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

Primary Purpose

Neuropathic Pain

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 Neuropathic Pain focused on measuring post-traumatic peripheral neuropathic pain

Eligibility Criteria

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

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.

Sites / Locations

  • Tennesse Valley Pain Consultants
  • Dedicated Clinical Research
  • Elite Clinical Studies, LLC
  • HOPE Research Institute
  • The Pain Center of Arizona
  • Arizona Research Center
  • The Pain Center of Arizona
  • Neuromuscular Research Center
  • Quality of Life Medical & Research Centers, LLC
  • Advanced Rx Clinical Research
  • Behavioral Research Specialists, LLC
  • NervePro Medical Corp.
  • University of California, Irvine
  • Clinical and Translational Research Institute
  • Alliance Research Centers
  • South Orange County Surgical Medical Group
  • Center For United Research, Inc.
  • University of Southern California
  • USC I.D.S. Pharmacy
  • Samaritan Center for Medical Research
  • North County Clinical Research
  • Allied Clinical Research
  • Northern California Research
  • Diablo Clinical Research, Inc.
  • Elite Clinical Trials, Inc.
  • Colorado Clinic
  • Mountain View Clinical Research Inc.
  • St. Luke's Medical Clinic
  • Investigational Drug Services, The George Washington University Medical Center
  • The George Washington University Medical Center (Department of Neurology)
  • The George Washington University Medical Center
  • Orthopedic Research Institute
  • Advance Medical Research
  • Innovative Research of West Florida
  • Aga Clinical Trials
  • Health Care Family Rehab & Research Center
  • Research in Miami, Inc.
  • Homestead Medical Research , Inc.
  • AMPM Research Clinic
  • San Marcus Research Clinic, Inc.
  • Advanced Pharma CR, LLC
  • Florida International Research Center
  • Kendall South Medical Center, Inc.
  • Compass Research, LLC
  • A-One Family Practice
  • Aba Family Medicine, LLC
  • Ribo Research, LLC dba Peninsula Resarch
  • Comprehensive Pain Care of South Florida
  • Sarasota Pain Medicine Research
  • Meridien Research
  • Atlanta Center for Medical Research
  • Columbus Regional Research Institute
  • Georgia Institute for Clinical Research, LLC
  • Advanced Internal Medicine, PC
  • Research 1 Clinical Research Network, Inc. (Administrative Office Only)
  • Rehabilitation Institute of Chicago
  • Chicago Anesthesia Associates
  • Kansas City Bone & Joint Clinic
  • Otri-Med Corporation
  • Central Kentucky Research Associates, Inc.
  • Centex Studies, Inc
  • Massachusetts General Hospital
  • Michigan Head Pain and Neurological Institute
  • Medex Healthcare Research, Inc.
  • Quality Clinical Research, Inc.
  • Heartland Clinical Research, Inc.
  • Advanced Biomedical Research of America
  • University of Rochester, Translational Pain Research
  • PMG Research of Charlotte
  • PMG Research of Winston-Salem
  • Northern Ohio Neurosciences, LLC
  • Wells Institute for Health Awareness
  • Northwest Ohio Research Center, LLC
  • Robert L Kalb, M.D, Inc
  • Cor Clinical Research, Llc
  • Lynn Health Science Institute
  • Summit Research Network, Inc.
  • Allegheny Pain Management, P.C.
  • CRI Lifetree
  • Pharmacorp Clinical Trials, Inc.
  • TLM Medical Services, LLC
  • Piedmont Comprehensive Pain Management Group, LLC
  • Pharmacum Biomedical Research
  • New Phase Research and Development
  • Dallas Pain Consultants
  • FutureSearch Trials of Dallas, L. P.
  • Abigail R. Neiman, MD, PA
  • Agadadash Kuliev, MD, PA
  • Biopharma Informatic Inc. Research Center
  • Medstar Clinical Research Associates
  • ClinRx Research, LLC
  • DCT - Stone Oak, LLC dba Discovery Clinical Trials
  • Sealy Urgent Care Center and Medical Clinic
  • Grayline Clinical Drug Trials
  • Lifetree Clinical Research
  • J. Lewis Research, Inc./Foothill Family Clinic
  • J. Lewish Research, Inc./Foothill Family Clinic South
  • Integrated Neurology Services , PLLC
  • IntegraTrials, LLC
  • Washington Center for Pain Management LLC
  • Northwest Clinical Research Center
  • Washington Center for Pain Management LLC
  • Washington Center for Pain Management LLC
  • Washington Center for Pain Management LLC
  • Summit Research Network (Seattle) LLC
  • MHAT Puls AD
  • MHAT "Avis Medika"
  • MHAT "Sv.Pantaleymon"
  • DCC Akta Medika Ltd.
  • UMHAT Aleksandrovska
  • DCC "Sveta Anna"EOOD
  • Aggarwal and Associates Limited
  • NRK Medical Research Clinic (Adminstrative Office Only)
  • NRK Medical Research Clinic
  • London Road Diagnostic Clinic and Medical Centre
  • General Hospital "dr. Ivo Pedisic"
  • Glostrup Hospital
  • Klinische Forschung Hannover-Mitte GmbH
  • Praxis für Spezielle Schmerztherapie und Palliativmedizin
  • medamed GmbH Studienambulanz
  • pro scientia med im MARE Klinikum
  • Klinische Forschung Berlin-Mitte GmbH
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Klinische Forschung Hamburg GmbH
  • Gemeinschaftspraxis für Schmerz- und Psychotherapie
  • Synexus Clinical Research GmbH
  • Klinische Forschung Schwerin GmbH
  • Synexus Magyarorszag Kft.
  • UNO Medical Trials Kft
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Seoul National University Hospital
  • 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
  • Malopolskie Centrum Medyczne S.C.
  • NZOZ IGNIS dr n. med. Alicja Lobinska
  • "SYNEXUS Polska" Sp. z o.o. ODDZIAL W WARSZAWIE
  • "SYNEXUS POLSKA" Sp. z o.o. Odzial we Wroclawiu
  • Ponce School of Medicine, CAIMED Center
  • Centrul Medical Sana
  • Clubul Sanatatii SRL
  • Spitalul Clinic de Neuropsihiatrie Craiova
  • Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I
  • Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie
  • Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II
  • Welkom Clinical Trial Centre
  • Synexus SA - Stanza Clinical Research Centre
  • Synexus SA - Watermeyer Clinical Research Centre
  • Synexus SA - Roodepoort Medicross Clinical Research Centre
  • Ladulaas Kliniken
  • CTC, Gothia Forum, Sahlgrenska Universitetssjukhus
  • Probare
  • Pharmasite
  • Bragee Medect AB

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pregabalin

placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 3, 2012
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
NCT01701362
Brief Title
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
post-traumatic peripheral neuropathic pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
Lyrica, PD-144723
Intervention Description
capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
Primary Outcome Measure Information:
Title
Baseline Mean Pain Score
Description
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.
Time Frame
Baseline
Title
Change From Baseline to Week 15 in Weekly Mean Pain Score
Description
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.
Time Frame
up to Week 15
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC) at Week 15
Description
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.
Time Frame
Week 15
Title
Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)
Description
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.
Time Frame
up to Week 15
Title
Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])
Description
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.
Time Frame
Week 15
Title
Change From Baseline in Pain Interference Index (BPI-sf)
Description
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.
Time Frame
Week 15
Title
Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores
Description
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.
Time Frame
Week 15
Title
Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
Description
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.
Time Frame
Baseline
Title
Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
Description
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.
Time Frame
Week 15
Title
Percentage of Participants in MOS-SS With Optimal Sleep Status.
Description
MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.
Time Frame
Week 15
Title
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.
Description
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.
Time Frame
Week 15
Title
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%
Description
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.
Time Frame
Week 15

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30242745
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081279&StudyName=Placebo-controlled%20safety%20and%20efficacy%20study%20of%20pregabalin%20in%20subjects%20with%20post-traumatic%20peripheral%20neuropathic%20pain
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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