Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37528   clinical trials with a EudraCT protocol, of which   6154   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2008-005107-26
    Sponsor's Protocol Code Number:242-07-208
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-27
    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 ConcernedLatvia - SAM
    A.2EudraCT number2008-005107-26
    A.3Full title of the trial
    A Phase 2, Multi-center, Uncontrolled, Open-label Trial to Evaluate Safety, tolerability, and Efficacy of Orally Administered OPC-67683 as 100 mg BID with optional titration to 200 mg BID for up to Six Months Exposure in Patients with Pulmonary Multi-drug Resistant Tuberculosis
    A.4.1Sponsor's protocol code number242-07-208
    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
    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
    The primary objective of this trial is to provide extended safety and tolerability data for MDR TB patients from longer-term exposure with OPC-67683 up to 6 additional months beyond exposure in 242-07-204.
    E.2.2Secondary objectives of the trial
    The secondary objective of this trial is to evaluate efficacy of OPC-67683 administered as either 100 mg BID (twice daily) with an option to titrate to 200 mg BID orally administered in combination with Optimized Background Treatment Regimen (OBR) for up to 6 months of exposure in patients who have completed the 242-07-204 trial. Also, this trial will provide additional access or first time access (for patients who received placebo) to OPC-67683 for patients who have completed the 242-07-204 trial and who may continue to receive clinical benefit from OPC-67683 exposure
    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 or female patients aged between 18 and 64 years, inclusive, at the time of
    enrollment into the 242-07-204 trial. Patients who were 64 years at the time of
    204 enrollment and who are now 65 years, are eligible for this trial.
    3) Patients who have completed trial 242-07-204.
    4) Patients judged by the investigator to have the potential for clinical benefit from
    OPC-67683 exposure.
    5) Able to produce sputum for mycobacterial culture or able to obtain sputum
    produced through induction.
    6) 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.
    7) 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.
    E.4Principal exclusion criteria
    1) Greater than 30 days has elapsed from the patient’s date of completion in the 242-
    07-204 trial or greater than 30 days has elapsed since the patient’s trial
    investigator’s site was initiated in this trial, whichever is later.
    2) A history of allergy to any nitro-imidazoles or nitro-imidazole derivates at any
    time.
    3) 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.
    4) Any current serious concomitant conditions or renal impairment characterized by
    serum creatinine levels ≥265 ╬╝mol/L or hepatic impairment characterized by ALT
    and/or aspartate transferase (AST) levels 3 times the upper limit of the laboratory
    reference range from the screening lab results.
    5) Current clinically relevant changes in the ECG (between Trial 204 day 56
    assessment and baseline) such as any atrioventricular (AV) block, prolongation of
    the QRS complex over 120 msec (in both male and female patients), or the QTcF
    interval over 450 msec in male patients and 470 msec in female patients.
    6) Current clinically relevant cardiovascular disorder such as heart failure, coronary
    artery disease, uncontrolled or poorly controlled hypertension, arrhythmia,
    tachyarrhythmia or status after myocardial infarction.
    7) Any patients with known or reported significant psychiatric history.
    8) For patients with HIV infection, CD4 cell count < 350/mm3 or on treatment with
    anti-retroviral medication for HIV infection.
    9) Karnofsky score < 50% while hospitalized and <60% while not hospitalized.
    10) Any current diseases or conditions in which the use of nitro-imidazoles or nitroimidazole
    derivates is contra-indicated.
    11) Evidence of clinically significant metabolic, gastrointestinal, neurological,
    psychiatric or endocrine diseases, malignancy, or other abnormalities (other than
    the indication being studied).
    12) 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.
    13) Administered an IMP within 1-month prior to Visit 1 other than OPC-67683
    given as IMP in trial 242-07-204.
    14) Pregnant, breast-feeding, or planning to conceive or father a child within the
    timeframe described in the informed consent form.
    15) 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 or products prescribed by a
    physician for a non-abuse related indication.
    16) Any disorder that in the judgment of the investigator makes the patient 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)
    • Vital signs (blood pressure, heart rate, body temperature and body weight).
    • Standard 12-lead ECG.
    • Hematology, chemistry, and urinalysis
    • Audiometry
    • Visual acuity
    • Neurological and psychiatric assessments; please refer to the trial operations
    manual for details on the neurological and psychiatric assessments to be
    performed.
    • Coagulation (PT and aPTT)
    • Cortisol
    • Thyroid function tests
    • Concomitant medication usage
    • AEs and IREs, as observed by the investigator or reported by the patient
    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 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.8.3 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 concerned1
    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 must complete the assessments for early termination as outlined in Section 3.7.1 of the protocol.
    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 months2
    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 months2
    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 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 100
    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 Decision2009-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-22
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA