P4 (Pregabalin for Peripheral Posttraumatic Pain)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00292188
First received: February 13, 2006
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Neuralgia
Drug: pregabalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary [ Time Frame: each day of Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 255
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: pregabalin
pregabalin
Placebo Comparator: Placebo Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292188

  Show 44 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00292188     History of Changes
Other Study ID Numbers: A0081064
Study First Received: February 13, 2006
Results First Received: May 27, 2009
Last Updated: April 22, 2011
Health Authority: United Kingdom: Department of Health

Keywords provided by Pfizer:
Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 23, 2014