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. )

Tracking Information
First Submitted Date  ICMJE February 13, 2006
First Posted Date  ICMJE February 15, 2006
Results First Submitted Date  ICMJE May 27, 2009
Results First Posted Date  ICMJE October 5, 2009
Last Update Posted Date February 9, 2021
Study Start Date  ICMJE January 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2006)
Weekly Mean Pain Score at Week 8 (or early termination, last observation carried forward [LOCF]) from Daily Pain Diary
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2009)
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2006)
Hospital Anxiety and Depression Scale (HADS) Anxiety sub-scale score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P4 (Pregabalin for Peripheral Posttraumatic Pain)
Official Title  ICMJE A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
Brief Summary To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia
Intervention  ICMJE
  • Drug: pregabalin
    pregabalin
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: Active
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2011)
255
Original Enrollment  ICMJE
 (submitted: February 13, 2006)
260
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Denmark,   Finland,   Italy,   Netherlands,   Portugal,   Romania,   Sweden,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00292188
Other Study ID Numbers  ICMJE A0081064
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP