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Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study (PINPOINT)

Primary Purpose

Low Back Pain, Neuralgia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain focused on measuring identification, chronic, neuropathic, low back pain, primary care, pregabalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
  • Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
  • Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.
  • Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).

Exclusion Criteria:

  • A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only.
  • Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min).
  • Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.
  • Patients who have undergone previous surgery for back pain.
  • Patients who are using high doses of opioid medication (morphine > 60 mg per day).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pregabalin

    Arm Description

    Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen.

    Outcomes

    Primary Outcome Measures

    The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline.
    The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).

    Secondary Outcome Measures

    The time to onset of 30% pain reduction (as measured by the NRS mean pain score).
    The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.
    The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.
    The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.
    The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.
    The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12).
    The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
    The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
    The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice.
    The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study.

    Full Information

    First Posted
    February 16, 2011
    Last Updated
    January 21, 2021
    Sponsor
    Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01298466
    Brief Title
    Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study
    Acronym
    PINPOINT
    Official Title
    Open-Labeled European Study To Support The Early Identification Of Patients With Chronic Neuropathic Low Back Pain In Primary Care And To Assess The Effectiveness And Tolerability Of Pregabalin In This Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    February 2013 (Anticipated)
    Study Completion Date
    February 2013 (Anticipated)

    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
    A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Neuralgia
    Keywords
    identification, chronic, neuropathic, low back pain, primary care, pregabalin

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregabalin
    Arm Type
    Experimental
    Arm Description
    Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen.
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin
    Intervention Description
    The investigator will administer pregabalin in a flexible dose-escalation regimen as follows: 150 mg per night for 1 week, 300 mg per day for 1 week, 450 mg per day for 1 week, then 600 mg per day through to the end of the study. Patients may change the dose of medication based on individual response and tolerability as determined by the investigator.
    Primary Outcome Measure Information:
    Title
    The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline.
    Time Frame
    12 weeks
    Title
    The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    The time to onset of 30% pain reduction (as measured by the NRS mean pain score).
    Time Frame
    12 weeks
    Title
    The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.
    Time Frame
    12 weeks
    Title
    The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.
    Time Frame
    12 weeks
    Title
    The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.
    Time Frame
    12 weeks
    Title
    The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.
    Time Frame
    12 weeks
    Title
    The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12).
    Time Frame
    12 weeks
    Title
    The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
    Time Frame
    12 weeks
    Title
    The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).
    Time Frame
    12 weeks
    Title
    The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice.
    Time Frame
    12 weeks
    Title
    The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study. Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening. Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period. Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study). Exclusion Criteria: A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only. Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min). Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study. Patients who have undergone previous surgery for back pain. Patients who are using high doses of opioid medication (morphine > 60 mg per day).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081256&StudyName=Primary%20Care%20Identification%20Of%20Patients%20With%20Chronic%20Neuropathic%20Low%20Back%20Pain%20Study
    Description
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