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    Summary
    EudraCT Number:2007-001140-47
    Sponsor's Protocol Code Number:M10-014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-001140-47
    A.3Full title of the trial
    The primary objective of this study is to compare the analgesic efficacy and the safety of ABT-894 (6 mg tablets) administered twice daily (BID) to placebo in the treatment of diabetic neuropathic pain (DNP).Additionally, this study will also explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the DNP population.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberM10-014
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 No
    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 nameABT-894
    D.3.2Product code ABT-894
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 876170-44-4
    D.3.9.2Current sponsor codeA-422894.112
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 placeboTablet
    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
    diabetic neuropathic pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10054095
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the analgesic efficacy and the safety of ABT-894 (6 mg tablets) administered twice daily (BID) to placebo in the treatment of diabetic neuropathic pain (DNP).
    E.2.2Secondary objectives of the trial
    Additionally, this study will also explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the DNP population.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Subject must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the conduct of any study-specific procedures.
    2.Subject is male or female between 18 and 70 years of age (inclusive) at the Screening Visit.
    3.The subject must have a score of 3 or greater on the physical assessment portion of the Michigan Neuropathic Screening Instrument at the Screening Visit.
    4.At the Baseline Visit the subject must meet the following criteria:
    ·An average score of 4 or greater on the 24-hour average pain score (11-Point Likert Scale) collected for approximately 7 days prior to the Baseline Visit, and
    ·A compliance rating of no less than 60% on the 24-hour average pain score (11 Point Likert Scale) collected over approximately 7 days prior to the Baseline Visit.
    5.Subject must have an average of 4 or greater on the BPI average of pain score at the Baseline Visit.
    6.Subjects must be able to adhere to the study visit schedule and all other protocol requirements, including the completion of daily pain diaries.
    If female, subject is either not of childbearing potential (defined as postmenopausal for at least two (2) years or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or subject is of childbearing potential and practicing at least one (1) of the following methods of birth control:
    ·Total abstinence from sexual intercourse (minimum 1 complete menstrual cycle)
    ·A vasectomized partner
    ·Contraceptives (oral, parenteral or transdermal) for 3 consecutive months prior to study drug administration, or use of an intrauterine device
    ·Double-barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or creams) for a minimum of 1 complete menstrual cycle.
    8.If female, subject must have negative results for pregnancy tests performed:
    ·On serum sample obtained at the Screening Visit within 21 days prior to initial study drug administration, and
    ·Prior to dosing on a urine sample.
    9.The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy.
    10.Subject's distal symmetric diabetic polyneuropathy must be present for a minimum of six (6) months and should have begun in the feet with relative symmetrical onset.
    11.Subject has an HgbA1c £ 9. Subjects who have an HgbA1c > 9 and £ 11 may be included in the study upon the Investigator's consultation with the Abbott Medical Monitor.
    12.Subject must be willing to washout of all analgesics (except stable doses of NSAIDs for conditions other than DNP) for at least 5 half-lives of the longest acting analgesic or 2 days whichever is longer and be willing to remain off of medication during the 7 days prior to the Baseline Visit.
    E.4Principal exclusion criteria
    1.Subject has a history of an allergic reaction or clinically significant sensitivity or intolerance to acetaminophen or a NNR agonist.
    2.Subject has a medical condition or illness, which is not well controlled that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain and other symptoms of DNP.
    3.Subject has a symptomatic diagnosis of fibromyalgia that requires treatment. Subjects who have a diagnosis of fibromyalgia, but do not require treatment, may be included in the study upon the Investigator's consultation with the Abbott Medical Monitor.
    4.Subject is currently receiving analgesics for conditions other than DNP, except for stable doses of NSAIDs for a non-neuropathic pain condition (e.g. Osteoarthritis).
    5.Subject has a clinically symptomatic neuropathic pain condition other than DNP.
    6.Subject requires treatment with a NSAID for a non-neuropathic pain condition (e.g., non-selective or COX-2 inhibitors) at a dose that has not been stable for at least 30 days. If the subject is on a stable dose of NSAIDs (> 30 days), inclusion into the study may be permitted upon discussion with the Abbott Medical Monitor.
    7.Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
    8.Subject has a history of:
    ·Seizures, including those requiring treatment with anticonvulsant. Febrile seizures will be permitted at the discretion of the Investigator.
    ·Major depressive episode within the past two (2) years (as defined by DSMV IV)
    . Treated major depressive disorder within the past two years may be included upon the Investigator's consultation with the Abbott Medical Monitor.
    ·Major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
    ·Other psychiatric disorders as determined by the Investigator.
    9.Subject has a history of myocardial infarction (MI).
    10.Subject has unstable angina.
    11.Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
    12.Subject has undergone a cardiac revascularization procedure.
    13.Subject has New York Heart Association (NYHA) functional heart failure classification of Class III or greater.
    14.Has stable angina and has had their anti-anginal medication changed or altered within the last 3 months.
    15.Uncontrolled hypertension (HTN) defined as a systolic BP ³ 150 and/or a diastolic blood pressure ³ 100 at two consecutive visits (Screening and Baseline).
    16.Subject has a clinically significant abnormal ECG at Screening.
    17.Subject has any clinically significant infection/injury/illness within thirty (30) days prior to the Screening Visit.
    18.Subject has a newly diagnosed clinically significant medical condition that requires therapeutic intervention (within thirty [30] days prior to the Screening Visit) or unstable medical condition that significantly impacts health.
    (Criteria n. 19-32 omissis)
    E.5 End points
    E.5.1Primary end point(s)
    The weekly mean of 24-hour average pain score measured by the 11 point Likert Scale and calculated from subject's daily diary.
    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 Yes
    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 Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 years1
    E.8.9.1In the Member State concerned months1
    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 months2
    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 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 2007-12-10. 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 110
    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 Decision2008-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-23
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