P4 (Pregabalin for Peripheral Posttraumatic Pain) (P4)

A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain

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

Study Overview

• Status: Completed
• Conditions: Neuralgia
• Intervention / Treatment: Drug: Placebo; Drug: pregabalin

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • 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
    • Pfizer Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Pfizer Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Pfizer Investigational Site
  • Ontario
    • Sarnia, Ontario, Canada, N7T 4X3
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5G 1X5
      • Pfizer Investigational Site
• Denmark
  • Aarhus C, Denmark, 8000
    • Pfizer Investigational Site
  • Hvidovre, Denmark, 2650
    • Pfizer Investigational Site
• Finland
  • HUS, Finland, 00029
    • Pfizer Investigational Site
  • Tampere, Finland, 33520
    • Pfizer Investigational Site
• Italy
  • Milano, Italy, 20127
    • Pfizer Investigational Site
  • Montescano (PV), Italy, 27040
    • Pfizer Investigational Site
  • Roma, Italy, 00133
    • Pfizer Investigational Site
• Netherlands
  • 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
    • Pfizer Investigational Site
  • NB
    • Tilburg, NB, Netherlands, 5022 GC
      • Pfizer Investigational Site
  • NH
    • Amsterdam, NH, Netherlands, 1105 AZ
      • Pfizer Investigational Site
• Portugal
  • 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
    • Pfizer Investigational Site
• Romania
  • Bucharest, Romania, 050098
    • Pfizer Investigational Site
  • Bucuresti, Romania, 021155
    • Pfizer Investigational Site
  • Bucuresti, Romania, 76251
    • Pfizer Investigational Site
  • Iasi, Romania, 700661
    • Pfizer Investigational Site
• Sweden
  • Linkoping, Sweden, 581 85
    • Pfizer Investigational Site
  • Lund, Sweden, SE-22185
    • Pfizer Investigational Site
  • Stockholm, Sweden, 171 76
    • Pfizer Investigational Site
• Switzerland
  • Bern, Switzerland, CH-3010
    • Pfizer Investigational Site
  • Geneve 14, Switzerland, CH-1211
    • Pfizer Investigational Site
• United Kingdom
  • 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
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; placebo
EXPERIMENTAL: Active	Drug: pregabalin; pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	each day of Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 8
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	Week 8
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.	Week 8
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	Week 8
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.	Baseline through Week 8
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.	Baseline, Week 8
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.	Week 8
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.	Week 8
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.	Week 8
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.	Week 8
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.	Week 8
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.	Screening, Week 8
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.	Screening, Week 8
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.	Screening, Week 8
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.	Screening, Week 8
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.	Baseline, Week 8
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.	Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8
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.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: February 13, 2006
• First Submitted That Met QC Criteria: February 13, 2006
• First Posted (ESTIMATE): February 15, 2006

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081064