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    Summary
    EudraCT Number:2004-002948-10
    Sponsor's Protocol Code Number:A0081007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002948-10
    A.3Full title of the trial
    A Randomised Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects with Neuropathic Pain Associated with Lumbo-sacral Radiculopathy
    Estudio aleatorizado controlado con placebo sobre la eficacia y seguriad de Pregabalina en el tratamiento de sujetos con Dolor Neuropático asociado a Radiculopatía Lumbar
    A.4.1Sponsor's protocol code numberA0081007
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product namepregabalin
    D.3.2Product code PD 0144723 (CI-1008)
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codePD 0144723 (CI-1008)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product namepregabalin
    D.3.2Product code PD 0144723 (CI-1008)
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codePD 0144723 (CI-1008)
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product namepregabalin
    D.3.2Product code PD 0144723 (CI-1008)
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.2Current sponsor codePD 0144723 (CI-1008)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain associated with lumbo-sacral radiculopathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level VTc
    E.1.2Classification code 10050085
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of pregabalin in relieving neuropathic pain in subjects with lumbo-sacral radiculopathy by assessing time to a meaningful increase in pain or discontinuation from the study during double blind treatment
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of pregabalin for the treatment of subjects with chronic neuropathic pain due to lumbosacral radiculopathy;
    To evaluate responder rates at the end of single blind pregabalin treatment;
    To evaluate the number of days subjects experience mild, moderate and sever pain during screening, single blind flexible dose pregabalin and double blind treatment
    To evaluate improvement in subject reported sleep interference due to pain
    To evaluate the impact of treatment on subject reported levels of mood disturbance and anxiety
    To evaluate subject global impression of changeTo evaluate subject satisfaction with treatmentTo evaluate subject reported levels of disability, work productivity and other health outcomes measures
    To evaluate the effect of pregabalin treatment on health care utilisation
    To evaluate the impact of prior back surgery on subject response during single blind and double blind treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Male or female outpatients between 18 and 100 years of age.
    Females of childbearing potential must have a negative serum b-HCG pregnancy test and be practising an effective form of contraception. Women who have been surgically sterilised or are at least two years post-menopause do not have to use contraception.
    Pain consistent with a diagnosis of lumbosacral radiculopathy due to spinal stenosis or disk herniation. The pain must radiate to the calf or foot in manner consistent with L5 or S1 nerve root involvement. If the patient is experiencing pain in both the lower back and the calf or foot, the pain intensity in the calf or foot must be greater than that in the lower back. In addition, to ensure that patients entered into the study indeed have neuropathic pain due to L5 or S1 nerve root involvement, the subjects pain must be co-localised with areas of sensory changes or muscle weakness.
    The radicular pan must be present for at least 3 months and the subject’s pain must be stable for at least 4 weeks
    Subjects must complete the Daily Pain Rating Scale in the subject diary at least 75% of the time during screening and must have a mean weekly pain score of > 4 (visit 2).
    Subjects must be in generally good health, except for the presence of lumbo-sacral radiculopathy, based on physical examination and medical history. Other deviations must be determined as clinically insignificant by the investigator after discussion with Pfizer.
    Screening laboratory values must be within normal limits or abnormalities must be clinically insignificant in the judgment of the investigator.
    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 trial prior to study entry.
    Subject is willing and able to comply with trial procedures.
    E.4Principal exclusion criteria
    Pregnant or lactating women or women of childbearing potential not using acceptable method of contraception.
    Pending civil litigation or disability claims pertinent to the subject’s lumbo-sacral radiculopathy, current involvement in out-of-court settlements for claims pertinent to the subject’s lumbo-sacral radiculopathy or currently receiving monetary compensation as a result of any of the above
    Surgery for lumbosacral radiculopathy within the previous 6 months.
    More than one previous spinal surgery for pain/radiculopathy in the L5-S1 distribution
    Epidural injection for lumbo-sacral radiculopathy within the previous 6 weeks.
    Anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic anti-depressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study
    Presence of neuropathic pain due to lumbo-sacral radiculopathy for more than 4 years
    Neurologic disorders unrelated to lumbo-sacral radiculopathy that may confuse or confound the assessment of neuropathic pain due to lumbo-sacral radiculopathy. (eg primary or secondary nerve diseases) including but not limited to the following: familial neuropathies; toxic or pharmacologically induced neuropathies; infection related neuropathies; metabolic abnormalities; vascular, inflammatory, malignancy-mediated and immune-mediated neuropathies; spinal cord tumours; any progressive neurological disorder.
    Presence of any severe pain associated with conditions other than lumbo-sacral radiculopathy that may confound the assessment or self-evaluation of the pain
    Any clinically significant or unstable medical or psychiatric condition or laboratory abnormality that would compromise participation in the study, such as; significant renal disease; significant hepatic disorder; significant respiratory disorder; significant haematological disorders; significant immunological diseases; unstable cardiovascular disease; significant inflammatory or rheumatological disease; active Hepatitis B or C, HIV infection or any other significant infectious condition diagnosed within the past 3 months; symptomatic peripheral vascular disease; untreated endocrine disorders; creatinine clearance < 60 mL/min; total white blood cell count < 2500/mm3; platelet count < 100 x103/mm3.
    Clinically significant abnormal 12-lead ECG.
    Malignancy within the past 2 years, with the exception of basal cell carcinoma..
    Likelihood of requiring surgery during the course of the study.
    Recent abuse of illicit drugs or alcohol
    Participation in any previous clinical trials for pregabalin or participation in 2 or more previous clinical trials for pain related to lumbo-sacral radiculopathy.
    Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to screening.
    A previous history of intolerance or hypersensitivity to pregabalin or gabapentin.
    Any treatment with vigabatrin, hydroxychloroquine, deferoxamine, thiorizidine or any compound known to adversely affect the retina and visual field
    Use of prohibited medications as listed in the protocol in the absence of appropriate washout phase or the likelihood of requiring treatment during the study period with drugs not permitted by the protocol.
    Use of prohibited non-pharmacologic therapies in the 30 days prior to eligibility or the likelihood of engaging in these treatments during the study period.
    Illiterate or unable to complete the subject-rated assessment scales
    E.5 End points
    E.5.1Primary end point(s)
    Time to a meaningful increase in pain or discontinuation from the study during double blind treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 523
    F.4.2.2In the whole clinical trial 774
    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 Decision2005-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-19
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