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    Summary
    EudraCT Number:2007-005229-31
    Sponsor's Protocol Code Number:242-07-204
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-11
    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 ConcernedEstonia - SAM
    A.2EudraCT number2007-005229-31
    A.3Full title of the trial
    A Multi center, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Multiple Doses of OPC-67683 in Patients with Pulmonary Sputum Culture-Positive, Multidrug-resistant Tuberculosis
    A.4.1Sponsor's protocol code number242-07-204
    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 SponsorOtsuka Pharmaceutical Development and Commercialization, Inc.
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/07/524
    D.3 Description of the IMP
    D.3.1Product nameOPC-67683
    D.3.2Product code OPC-67683
    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.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeOPC-67683
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Pulmonary Multidrug-resistant Tuberculosis (MDR TB)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037440
    E.1.2Term Pulmonary tuberculosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety, efficacy and pharmacokinetics of 200 mg and 400 mg total daily doses of OPC-67683 administered orally as 100 mg twice daily and 200 mg
    twice daily in comparison to placebo for 56 consecutive days in combination with an optimized background treatment regimen (OBR) to patients with pulmonary, sputum culture-positive MDR TB
    E.2.2Secondary objectives of the trial
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provide written, informed consent prior to all trial-related procedures
    2) Male and female patients aged between 18 and 64 years, inclusive.
    3) Either mycobacterial culture of sputum positive for growth of M. tuberculosis or
    sputum smear positive for acid fast bacilli within 60 days from the time of sputum
    collection for the respective culture or smear until the expected date of enrollment
    (defined as the date the ICF is signed and screening begins).
    4) Patient with TB caused by isolates of M. tuberculosis complex confirmed to be
    resistant to treatment with isoniazid and rifampicin, or with positive rapid test for
    rifampicin resistance on direct sputum positive for acid fast bacilli or on culture
    positive for growth of M. tuberculosis within 60 days prior to the expected date of
    enrollment performed on sputum samples described above in criterion #3.
    5) Findings on chest radiograph consistent with TB.
    6) Able to produce sputum for mycobacterial culture.
    7) Female patients of childbearing potential must have a negative urine pregnancy
    test and agree to use a highly effective method of birth control (for example, two
    of the following precautions: tubal ligation, vaginal diaphragm, intrauterine
    device, oral contraceptives, contraceptive implant, combined hormonal patch,
    combined injectable contraceptive or depot-medroxyprogesterone acetate)
    throughout the participation in the trial and for 22 weeks after last dose (to cover
    duration of ovulation).
    8) Male patients must agree to use an adequate method of contraception (double
    barrier) throughout the participation in the trial and for 30weeks after last dose (to
    cover duration of spermatogenesis).
    E.4Principal exclusion criteria
    1) A history of allergy to any nitro-imidazoles or nitro-imidazole derivates at any
    time.
    2) Use of the medications in Section 4.1 including: use of amiodarone at any time
    during the previous 12 months, use of other anti-arrhthymics for the previous 30
    days, and use of certain other medications, including certain anti-depressants,
    anti-histamines, and macrolides, for the previous 14 days.
    3) Any current serious concomitant conditions or renal impairment characterized by
    serum creatinine levels ≥265 μmol/L or hepatic impairment characterized by ALT
    and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory
    reference range.
    4) Current clinically relevant changes in the screening ECG such as any
    atrioventricular (AV) block, prolongation of the QRS complex over 120 msec (in
    both male and female patients), or of QTcF interval over 450 msec in male
    patients and 470 msec in female patients.
    5) Current clinically relevant cardiovascular disorder such as heart failure, coronary
    heart disease, hypertension, arrhythmia, tachyarrhythmia or status after
    myocardial infarction.
    6) For patients with HIV infection, CD4 cell count < 350/mm3 or on treatment with
    anti-retroviral medication for HIV infection.
    7) Karnofsky score < 50%
    8) Any diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole
    derivates is contra-indicated.
    9) Evidence of clinically significant metabolic, gastrointestinal, neurological,
    psychiatric or endocrine diseases, malignancy, or other abnormalities (other than
    the indication being studied).
    10) Known or suspected alcohol abuse, that is, abuse sufficient enough to
    compromise the safety or cooperation of the patient in the opinion of the
    investigator.
    11) Administered an IMP within 1-month prior to Visit 1 (Screening [Days -12 to -
    3]).
    12) Pregnant, breast-feeding, or planning to conceive or father a child within the
    timeframe described in the informed consent form.
    13) Recent use of methadone, benzodiazepines, cocaine,
    amphetamine/metamphetamine, tetrahydrocannabinol, barbiturates, and opiates as
    determined by a urine drug screen unless evidence is provided that the positive
    drug screen is the result of authorized medications products prescribed by a
    physician for a non abuse related indication.
    14) Any disorder that in the judgment of the investigator makes the subject not a good
    candidate for the trial or may prevent the patient from reliably participating in the
    entire course of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    The primary efficacy endpoint is the proportion of subjects who achieve sputum
    mycobacterial culture negative for growth using the MGIT system, ie, sputum culture conversion, within 56 days. Sputum culture conversion is defined to occur at the time of the collection of a sputum specimen with mycobacterial culture negative for growth of M. tuberculosis followed by at least one additional sputum specimen with mycobacterial culture negative for growth at least 27 days after the first specimen and not followed by any sputum specimens with a mycobacterial culture positive for growth of M. tuberculosis at any point during the remainder of the 84-day trial.

    PK:
    For OPC-67683, tmax, Cmax, AUC0-24h, ratios of accumulation for Cmax and AUC0-24h [Rac(Cmax) and Rac(AUC), Day 14, 28 or 56/Day 1] will be determined.
    For OPC-67683 metabolites, tmax, Cmax, AUC0-24h, Rac(Cmax) and Rac(AUC) [Day 14, 28 or 56/Day 1], and t1/2,z will be determined.

    Safety:
    Reported adverse events, physical examination, vital signs (blood pressure, heart rate, body temperature and weight), standard 12-lead ECG, clinical laboratory assessment results (hematology, chemistry, urinalysis).
    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 No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Yes
    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
    The end of trial date for each individual patient is defined as the last date of contact or the date of final contact attempt as noted on the End of Trial page on the patient’s CRF. All patients who prematurely withdraw from the trial during the Treatment Period, that is Visits 4 to 59 (Days 1 to 56) for all treatment groups must complete the assessments for early termination.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 430
    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)
    none
    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 Decision2008-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-22
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