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    Summary
    EudraCT Number:2008-008339-27
    Sponsor's Protocol Code Number:A0081107
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-06
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-008339-27
    A.3Full title of the trial
    A 17-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTI-CENTER TRIAL OF PREGABALIN FOR THE TREATMENT OF CHRONIC CENTRAL NEUROPATHIC PAIN AFTER SPINAL CORD INJURY
    A.4.1Sponsor's protocol code numberA0081107
    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 Inc., 235 East 42nd Street, New York, NY10017
    B.1.3.4CountryUnited States
    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 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 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.3.9.1CAS number 148-553-50-8
    D.3.9.2Current sponsor codeLyrica
    D.3.9.3Other descriptive name(S)-3-(aminomethyl)-5-mehylhexanoic acid
    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 No
    D.3.11.8Extractive medicinal product No
    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 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 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.3.9.1CAS number 148-553-50-8
    D.3.9.2Current sponsor codeLyrica
    D.3.9.3Other descriptive name(S)-3-(aminomethyl)-5-mehylhexanoic acid
    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 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 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 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.3.9.1CAS number 148-553-50-8
    D.3.9.2Current sponsor codeLyrica
    D.3.9.3Other descriptive name(S)-3-(aminomethyl)-5-mehylhexanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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 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: 4
    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 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.3.9.1CAS number 148-553-50-8
    D.3.9.2Current sponsor codeLyrica
    D.3.9.3Other descriptive name(S)-3-(aminomethyl)-5-mehylhexanoic acid
    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 No
    D.3.11.8Extractive medicinal product No
    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, hard
    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
    Chronic Central Neuropathic Pain after Spinal Cord Injury.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    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 compared with placebo for the treatment of chronic central neuropathic pain after spinal cord injury.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of pregabalin in the treatment of chronic central neuropathic pain after spinal cord injury.
    • To evaluate the effect of pregabalin on the following items in subjects with chronic
    central neuropathic pain after spinal cord injury:
    a. Pain-related sleep interference and overall sleep disturbance;
    b. Self-reported symptoms of depression and anxiety;
    c. Patient global impressions of change and quality of life;
    d. Functional limitations due to pain interference;
    e. Neuropathic pain symptoms;
    f. Quantitative assessment of neuropathic pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are able and willing to provide informed consent; 2. Male and non-pregnant, non-lactating, postmenopausal, or surgically sterilized female subjects at least 18 years of age, of any ethnic origin; males and females of childbearing potential must use of contraception; all females must have a confirmed negative serum pregnancy test prior to randomization;3. Subjects deemed to comply with study schedule, procedures and medications as specified by the protocol; 4. Subjects with a documented diagnosis of spinal cord injury (SCI) including all of the
    following: - Outpatient or inpatient subjects; SCI resulting from accident (examples include motor vehicle, fall, gunshot, electric shock); SCI from diving; SCI due to spinal cord ischemia, Post-surgical SCI after benign tumor (except meningiomas and fibromas) has been removed and the level of injury has been stable for at least 6 months. 5. Complete or incomplete SCI of at least 12 months duration: Complete SCI: Grade A on the American Spinal Injury Association (ASIA); Impairment Scale - No sensory or motor function is preserved in the sacral segments S4-S5; Incomplete SCI: Grade B - Sensory but no motor function is preserved below the neurological level and includes the sacral segments S4-S5; Incomplete SCI: Grade C - Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3 (0 to 2); Incomplete SCI: Grade D - Motor function is preserved below the neurological level,and at least half ot key muscles below the neurological level have a muscle grade greater than or equal to 3 (3 to 5). 6. Neurological examination findings consistent with SCI and/or appropriate radiographic/imaging studies (such as X-ray, CT, myelogram, MRI) demonstrating a corresponding anatomical lesion documented by present or past medical records; 7. The Neurological Level of Injury (NLI) must be from C2-T12 inclusive (the NLI is defined as the most caudal segment of the spinal cord with normal sensory and motor function). C2 and C3 lesions are permitted as long as the subject is able to breathe without assistance. Low thoracic NLI (T11-T12) are allowed as long as the subject does not have radicular pain; 8. Subjects may also be included if they have the following conditions as long as all other entry criteria are met: Central cord syndrome, Brown-Sequard syndrome and anterior cord syndrome; Pain Inclusion Criteria - Definitions:-
    Neurological Level of Injury (NLI) is defined as the most caudal segment of the
    spinal cord with normal sensory and motor function; “Below-level” pain is defined as more than two dermatomes below the NLI; “At-level”pain is defined as within two dermatomes either above or below the NLI; “Above-level”pain is defined as more than two dermatomes above the NLI; ASIA is American Spinal Injury Association; information and the dermatome chart/worksheet to help with assessment can be found at www.asiaspinalinjury.org, under Publications. 9. For the purpose of this study, the pain is chronic central neuropathic pain, defined as: Pain can be experienced unilaterally or bilaterally, and must have started after the spinal cord injury and persisted continuously for at least 3 months or with remissions and relapses for at least 6 months; Below-level neuropathic pain according to the Bryce-Ragnarsson SCI pain taxonomy type 14 or 15(to the power of 47). Type 14. SCI below level central pain is neuropathic pain which occurs caudal to the two dermatomal levels below the neurological level of injury (NLI). Its distribution is generally not dermatomal but regional, enveloping large areas such as the anal region, the bladder, the genitals, the legs, or commonly the entire body below the neurologic level. The character is often described as ‘burning' or ‘aching,' although other descriptors have included ‘pressure,' ‘heaviness,' ‘cold,' ‘numbness,' and ‘pins and needles'. It is usually continuous in presence, although the intensity of the pain can fluctuate in response to a number of factors including psychological stress, anxiety, fatigue, smoking, noxious stimuli below the level of injury, and weather changes ; Type 15. SCI ‘below level' neuropathic—other pain occurs only in persons with a neurologically incomplete SCI or complete SCI with a zone of partial preservation (ZPP) extending to the level of the pain. It includes all the neuropathic types of pain which are not specifically known to be more common after SCI, and which occur in areas innervated by segments more than two levels below the neurological level of injury; Subject must have “below-level” pain; At-level or above-level pain can be present as long as the subject also has below-level pain.
    Inclusion Criteria (randomization)
    Completed at least 4daily pain diary entries during the 7 days prior to randomization with an average score of: 4 on the 11-point rating scale for pain.
    E.4Principal exclusion criteria
    1. Pregnant or lactating females or females of childbearing potential not practicing an
    effective method of contraception;
    2. Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (including but not limited to pain due to hereditary neuropathies; compression-related neuropathies, ie, leprosy; diabetic peripheral neuropathy; traumatic neuropathy; metabolic abnormalities such as hypothyroidism; vascular, inflammatory, malignancy-mediated, and immune-mediated neuropathies;
    3. Preexisting myelopathy due to other causes;
    4. Congenital canal stenosis with trauma-induced spinal cord injury;
    5. Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury; 6. Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug
    7.Abuse or dependence of drugs or alcohol within the past 12 months according to the Diagnostic and statistical manual of mental disorders criteria (DSM-IV);
    8. Previous or current participation in another clinical study of pregabalin; intolerance
    to doses of pregabalin (150 to 600mg/day); pregabalin use within 60 days prior to
    screening;
    9. Concurrent or previous participation in another clinical trial within 30 days prior to
    screening;
    10. A previous history of intolerance or hypersensitivity to gabapentin or drugs with
    similar chemical structures;
    11. Anticipated need for surgery during the course of the study;
    12. Malignancy within the past year, with the exception of basal cell carcinoma, which
    is not exclusionary;
    13. Clinically significant or unstable medical condition that, in the opinion of the
    investigator, would compromise participation in the study;
    14. Mental or psychological condition rendering the subject unable to understand the
    requirements of participation in the study and risks/benefits thereof, and/or evidence
    of an uncooperative attitude in the judgment of the investigator;
    15. Significant psychiatric disorder, recurrent episodes of severe depression (any pharmacologic treatment or hospitalization for the illness within 1 year prior to Screening), or subjects with serious suicidal risk per criteria. A risk assessment should be done by a qualified mental health professional (MHP) to assess whether it is safe for the subject to participate in the trial if at least one of the following three conditions are met: Subject’s responses on the Sheehan-Suicidality Tracking Scale (Sheehan-STS, Lifetime Assessment version) Appendix 13 items 1a, 1b, 3 and 4, 5, 6, or 8 is positive (score ≥ 1); or, Subject’s total Patient Health Questionnaire-8 (PHQ-8) Appendix 11 score ≥ 15; or, Presence of any current major psychiatric disorder that is not explicitly permitted in the inclusion/exclusion criteria.The Sheehan-STS and PHQ-8 criteria are described in the Section 7 of the protocol. Subjects with mild, chronic depression without recent hospitalization who are being maintained on a stable dose of a single antidepressant are acceptable;
    16. Pending civil litigation or disability claims pertinent to the subjects spinal cord
    injury, current involvement in out-of-court settlements for claims pertinent to the
    subjects spinal cord injury, or other legal complications related to the spinal cord
    injury that could confound assessments;
    17. Likelihood of requiring treatment during the study period with drugs prohibited by
    the study protocol;
    18. A history of retinal abnormalities or treatment with retinotoxic agents
    19. Use of prohibited medications in the absence of appropriate washout periods
    Exclusion Criteria (randomization)
    1. Creatinine clearance <60 mL/min (estimated from serum creatinine). Subjects who
    have an estimated creatinine clearance <60 mL/min may, at the investigator's
    discretion, have their creatinine clearance measured with a serum sample and a
    24-hour urine collection obtained at an unplanned visit and analyzed at the central
    laboratory. If the 24-hour urine creatinine clearance is ≥ 60 mL/min, the subject may
    be randomized provided that all other inclusion/exclusion criteria have been
    satisfied;
    2. White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count
    <100 x 103/ mm3;
    3. Clinically significant abnormal electrocardiogram (ECG).
    E.5 End points
    E.5.1Primary end point(s)
    Duration adjusted average change (DAAC) derived from subject’s daily pain diary, where pain is measured on an 11-point rating Scale from 0 (no pain) to 10 (worst possible pain).
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 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
    Please see protocol
    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 months
    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 months9
    E.8.9.2In all countries concerned by the trial days26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 200
    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 Decision2009-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-28
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