Back to resultsP4 (Pregabalin for Peripheral Posttraumatic Pain) (P4)
Primary Purpose
Neuralgia
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia focused on measuring Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
Eligibility Criteria
Inclusion Criteria: Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event Exclusion Criteria: Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II) NeP not due to trauma, and not peripheral pain
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.
Secondary Outcome Measures
Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
Hospital Anxiety and Depression Scale (HADS) Depression Score
Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.
Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores
Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Weekly Mean Pain Score From Daily Pain Diary
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.
Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.
Weekly Mean Sleep Interference Score
11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.
Medical Outcome Study (MOS) Sleep Subscales
Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.
Medical Outcome Study (MOS) Optimal Sleep
Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Clinical Global Impression of Change (CGIC)
Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Pain Treatment Satisfaction Scale (PTSS): Efficacy
Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Modified Brief Pain Inventory Short Form (m-BPI-sf)
Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.
Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Davidson Trauma Scale (DTS): Severity
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Davidson Trauma Scale (DTS): Frequency
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Davidson Trauma Scale (DTS): Total Score
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Full Information
NCT ID
NCT00292188
First Posted
February 13, 2006
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00292188
Brief Title
P4 (Pregabalin for Peripheral Posttraumatic Pain)
Acronym
P4
Official Title
A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (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
No
5. Study Description
Brief Summary
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia
Keywords
Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
pregabalin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
Description
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.
Time Frame
each day of Week 8
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Description
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
Time Frame
Week 8
Title
Hospital Anxiety and Depression Scale (HADS) Depression Score
Description
Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time Frame
Week 8
Title
Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores
Description
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety.
Time Frame
Week 8
Title
Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores
Description
Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time Frame
Week 8
Title
Weekly Mean Pain Score From Daily Pain Diary
Description
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week.
Time Frame
Baseline through Week 8
Title
Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
Description
Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase.
Time Frame
Baseline, Week 8
Title
Weekly Mean Sleep Interference Score
Description
11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment.
Time Frame
Week 8
Title
Medical Outcome Study (MOS) Sleep Subscales
Description
Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance.
Time Frame
Week 8
Title
Medical Outcome Study (MOS) Optimal Sleep
Description
Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week.
Time Frame
Week 8
Title
Patient Global Impression of Change (PGIC)
Description
Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Time Frame
Week 8
Title
Clinical Global Impression of Change (CGIC)
Description
Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse.
Time Frame
Week 8
Title
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Description
Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame
Screening, Week 8
Title
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Description
Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame
Screening, Week 8
Title
Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
Description
Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame
Screening, Week 8
Title
Pain Treatment Satisfaction Scale (PTSS): Efficacy
Description
Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
Time Frame
Screening, Week 8
Title
Modified Brief Pain Inventory Short Form (m-BPI-sf)
Description
Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain.
Time Frame
Baseline, Week 8
Title
Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
Description
Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage.
Time Frame
Week 8
Title
Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
Description
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame
Baseline, Week 8
Title
Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
Description
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame
Baseline, Week 8
Title
Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
Description
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame
Baseline, Week 8
Title
Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
Description
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame
Baseline, Week 8
Title
Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
Description
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame
Baseline, Week 8
Title
Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
Description
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used.
Time Frame
Baseline, Week 8
Title
Davidson Trauma Scale (DTS): Severity
Description
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time Frame
Baseline, Week 8
Title
Davidson Trauma Scale (DTS): Frequency
Description
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time Frame
Baseline, Week 8
Title
Davidson Trauma Scale (DTS): Total Score
Description
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136.
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event
Exclusion Criteria:
Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
NeP not due to trauma, and not peripheral pain
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
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Genk
ZIP/Postal Code
B-3600
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
4020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Pellenberg
ZIP/Postal Code
B-3212
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Wilrijk
ZIP/Postal Code
B-2610
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Pfizer Investigational Site
City
HUS
ZIP/Postal Code
00029
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Montescano (PV)
ZIP/Postal Code
27040
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Pfizer Investigational Site
City
Tilburg
State/Province
NB
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Amsterdam
State/Province
NH
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Kampen
ZIP/Postal Code
8266 AB
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Funchal
ZIP/Postal Code
9004-514
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Guimarães
ZIP/Postal Code
4800-055
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
021155
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
76251
Country
Romania
Facility Name
Pfizer Investigational Site
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Geneve 14
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS14 6UH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21439051
Citation
van Seventer R, Serpell M, Bach FW, Morlion B, Zlateva G, Bushmakin AG, Cappelleri JC, Nimour M. Relationships between changes in pain severity and other patient-reported outcomes: an analysis in patients with posttraumatic peripheral neuropathic pain. Health Qual Life Outcomes. 2011 Mar 25;9:17. doi: 10.1186/1477-7525-9-17.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081064&StudyName=P4%20%28Pregabalin%20for%20Peripheral%20Posttraumatic%20Pain%29
Description
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Learn more about this trial
P4 (Pregabalin for Peripheral Posttraumatic Pain)
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