Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

P4 (Pregabalin for Peripheral Posttraumatic Pain) (P4)

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: NCT00292188
Recruitment Status : Completed
First Posted : February 15, 2006
Results First Posted : October 5, 2009
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief Summary:
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain

Condition or disease Intervention/treatment Phase
Neuralgia Drug: pregabalin Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
Study Start Date : January 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Active Drug: pregabalin
pregabalin

Placebo Comparator: Placebo Drug: Placebo
placebo




Primary Outcome Measures :
  1. Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary [ Time Frame: each day of Week 8 ]
    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 :
  1. Hospital Anxiety and Depression Scale (HADS) Anxiety Score [ Time Frame: Week 8 ]
    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

  2. Hospital Anxiety and Depression Scale (HADS) Depression Score [ Time Frame: Week 8 ]
    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

  3. Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores [ Time Frame: Week 8 ]
    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.

  4. Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores [ Time Frame: Week 8 ]
    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

  5. Weekly Mean Pain Score From Daily Pain Diary [ Time Frame: Baseline through Week 8 ]
    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.

  6. Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8) [ Time Frame: Baseline, 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.

  7. Weekly Mean Sleep Interference Score [ Time Frame: Week 8 ]
    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.

  8. Medical Outcome Study (MOS) Sleep Subscales [ Time Frame: Week 8 ]
    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.

  9. Medical Outcome Study (MOS) Optimal Sleep [ Time Frame: Week 8 ]
    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.

  10. Patient Global Impression of Change (PGIC) [ Time Frame: Week 8 ]
    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.

  11. Clinical Global Impression of Change (CGIC) [ Time Frame: Week 8 ]
    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.

  12. Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication [ Time Frame: Screening, Week 8 ]
    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.

  13. Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication [ Time Frame: Screening, Week 8 ]
    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.

  14. Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics [ Time Frame: Screening, Week 8 ]
    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.

  15. Pain Treatment Satisfaction Scale (PTSS): Efficacy [ Time Frame: Screening, Week 8 ]
    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.

  16. Modified Brief Pain Inventory Short Form (m-BPI-sf) [ Time Frame: Baseline, Week 8 ]
    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.

  17. Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score [ Time Frame: Week 8 ]
    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.

  18. Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning [ Time Frame: Baseline, Week 8 ]
    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.

  19. Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration [ Time Frame: Baseline, Week 8 ]
    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.

  20. Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion [ Time Frame: Baseline, Week 8 ]
    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.

  21. Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory [ Time Frame: Baseline, Week 8 ]
    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.

  22. Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention [ Time Frame: Baseline, Week 8 ]
    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.

  23. Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking [ Time Frame: Baseline, Week 8 ]
    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.

  24. Davidson Trauma Scale (DTS): Severity [ Time Frame: Baseline, Week 8 ]
    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.

  25. Davidson Trauma Scale (DTS): Frequency [ Time Frame: Baseline, Week 8 ]
    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.

  26. Davidson Trauma Scale (DTS): Total Score [ Time Frame: Baseline, Week 8 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00292188


Locations
Layout table for location information
Belgium
Pfizer Investigational Site
Brussels, Belgium, 1070
Pfizer Investigational Site
Genk, Belgium, B-3600
Pfizer Investigational Site
Liege, Belgium, 4020
Pfizer Investigational Site
Liège, Belgium, B-4000
Pfizer Investigational Site
Pellenberg, Belgium, B-3212
Pfizer Investigational Site
Wilrijk, Belgium, B-2610
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Pfizer Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 1X5
Denmark
Pfizer Investigational Site
Aarhus C, Denmark, 8000
Pfizer Investigational Site
Hvidovre, Denmark, 2650
Finland
Pfizer Investigational Site
HUS, Finland, 00029
Pfizer Investigational Site
Tampere, Finland, 33520
Italy
Pfizer Investigational Site
Milano, Italy, 20127
Pfizer Investigational Site
Montescano (PV), Italy, 27040
Pfizer Investigational Site
Roma, Italy, 00133
Netherlands
Pfizer Investigational Site
Tilburg, NB, Netherlands, 5022 GC
Pfizer Investigational Site
Amsterdam, NH, Netherlands, 1105 AZ
Pfizer Investigational Site
Alkmaar, Netherlands, 1815 JD
Pfizer Investigational Site
Breda, Netherlands, 4819 EV
Pfizer Investigational Site
Kampen, Netherlands, 8266 AB
Pfizer Investigational Site
Roosendaal, Netherlands, 4708 AE
Portugal
Pfizer Investigational Site
Almada, Portugal, 2801-951
Pfizer Investigational Site
Amadora, Portugal, 2720-276
Pfizer Investigational Site
Coimbra, Portugal, 3000-075
Pfizer Investigational Site
Funchal, Portugal, 9004-514
Pfizer Investigational Site
Guimarães, Portugal, 4800-055
Pfizer Investigational Site
Lisboa, Portugal, 1169-050
Pfizer Investigational Site
Lisboa, Portugal, 1649-035
Pfizer Investigational Site
Porto, Portugal, 4099-001
Romania
Pfizer Investigational Site
Bucharest, Romania, 050098
Pfizer Investigational Site
Bucuresti, Romania, 021155
Pfizer Investigational Site
Bucuresti, Romania, 76251
Pfizer Investigational Site
Iasi, Romania, 700661
Sweden
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Lund, Sweden, SE-22185
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Switzerland
Pfizer Investigational Site
Bern, Switzerland, CH-3010
Pfizer Investigational Site
Geneve 14, Switzerland, CH-1211
United Kingdom
Pfizer Investigational Site
Birmingham, United Kingdom, B29 6JD
Pfizer Investigational Site
Glasgow, United Kingdom, G12 0YN
Pfizer Investigational Site
Leeds, United Kingdom, LS14 6UH
Pfizer Investigational Site
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00292188    
Other Study ID Numbers: A0081064
First Posted: February 15, 2006    Key Record Dates
Results First Posted: October 5, 2009
Last Update Posted: February 9, 2021
Last Verified: April 2011
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
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