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    Summary
    EudraCT Number:2010-022955-43
    Sponsor's Protocol Code Number:A0081256
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2010-022955-43
    A.3Full title of the trial
    OPEN LABEL 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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPEN LABEL 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
    A.3.2Name or abbreviated title of the trial where available
    PINPOINT - Primary Care IdeNtification of Patients with chrOnic NeuropaThic low back pain
    A.4.1Sponsor's protocol code numberA0081256
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Ltd
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number001303739 1119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lyrica®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pregabalin (Lyrica ®) is approved in the European Union for the treatment of peripheral and central neuropathic pain in adults. The medical condition being investigated in this study is chronic neuropathic low back pain.
    E.1.1.1Medical condition in easily understood language
    Chronic Low Back Pain
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To raise awareness and enhance the diagnosis of patients with chronic low back pain(CLBP) with a neuropathic pain component who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain in a primary care setting and assess the effectiveness and tolerability of pregabalin in this group of patients.
    To assess patient satisfaction with treatment with pregabalin in patients with CLBP with a neuropathic pain component who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain in a primary care setting.
    E.2.2Secondary objectives of the trial
    To assess the time to achieve a clinically meaningful analgesic response with pregabalin by determining the time to onset of 30% pain reduction.
    To assess the impact of treatment with pregabalin on: anxiety and depression; sleep quality; absenteeism and labour productivity; physical functioning with respect to daily activities
    To assess the correlation between the observed changes in two different measures of neuropathic pain.
    To note the proportion of patients treated with pregabalin with a 30% reduction in pain from baseline at study endpoint and the proportion of patients with a 50% reduction in pain over the same period.
    To characterize the utility of screening tools to support the identification of patients with neuropathic chronic low back pain.
    To characterize the 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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    Adult patients (aged 18 years or over) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    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 baseline.
    Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period (based on patients having completed at least 4 daily pain diaries within the last 7 days).
    Patients must be taking stable pain medication (for 30 days).
    Patients must have failed to respond to standard analgesic therapy (eg, non-steroidal antiinflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (eg, tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).
    Female subjects of childbearing potential must not be pregnant or lactating at screening and must have a negative urine pregnancy test at screening (women post-menopausal for <2 years will also require a urine pregnancy test at screening).
    Female subjects of childbearing potential must be using effective contraception since the last date of their menses and continue to do so during the study period.
    E.4Principal exclusion criteria
    Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    Participation in other studies within 30 days before the current study begins and/or during study participation.
    Other severe acute or chronic medical condition (eg, cancer) or psychiatric condition including suicidal behaviour or active suicidal ideation) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    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 less than 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).
    Patients with a contraindication to receiving pregabalin as per the EU Summary of
    Product Characteristics (SmPC).
    Pregnant or lactating women, or women of childbearing potential including women less than two years post-menopausal not using an effective method of contraception.
    Patients scheduled to have planned or elective surgery during the course of the study.
    E.5 End points
    E.5.1Primary end point(s)
    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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 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.
    2. The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12)
    E.5.2Secondary end point(s)
    1.To assess the time to achieve a clinically meaningful analgesic response with pregabalin
    by determining the time to onset of 30% pain reduction.
    2.To assess the impact of treatment with pregabalin on anxiety and depression.
    3.To assess the impact of treatment with pregabalin on sleep quality.
    4.To assess the impact of treatment with pregabalin on absenteeism and labour
    productivity.
    5.To assess the impact of treatment with pregabalin on physical functioning with respect to daily activities.
    6.To assess the correlation between the observed changes in two different measures of
    neuropathic pain.
    7.To note the proportion of patients treated with pregabalin with a 30% reduction in pain
    from baseline at study endpoint and the proportion of patients with a 50% reduction in
    pain over the same period.
    8.To characterize the utility of screening tools to support the identification of patients with
    neuropathic chronic low back pain.
    9.To characterize the 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Time to onset of 30% pain reduction(measured by NRS mean pain score)
    2.Change in HADS score at the end of study(EOS) compared to Baseline 3.Change in Sleep Interference Scale score at the EOS compared to Baseline 4.Change in LWDE score at the EOS compared to Baseline 5.Change in RMDQ score at the EOS compared to Baseline 6.Change in PainDetect vs StEP scores at the EOS compared to Baseline
    7.Proportion of patients with a 30% reduction in pain at the EOS compared to Baseline
    8.Proportion of patients with a 50% reduction in pain at the EOS compared to Baseline
    9.Percentage of primary care physicians who find screening tools useful to support the detection of neuropathic CLBP in daily practice
    10.Nature & incidence of AEs for patients taking 150mg pregabalin at night as a single dose
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability & Effectiveness
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    As per protocol LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Will not be different from the expected normal treatment for chronic low back pain
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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