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    The EU Clinical Trials Register currently displays   43889   clinical trials with a EudraCT protocol, of which   7298   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).

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    EudraCT Number:2010-022271-59
    Sponsor's Protocol Code Number:242-09-213
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-30
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2010-022271-59
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis
    A.4.1Sponsor's protocol code number242-09-213
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOtsuka Pharmaceutical Development & 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Blvd.
    B.5.3.2Town/ cityRockville, MD
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+13019056710
    B.5.5Fax number+13017217243
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDelamanid
    D.3.2Product code OPC-67683
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNDelamanid
    D.3.9.1CAS number 681492-22-8
    D.3.9.2Current sponsor codeOPC-67683
    D.3.9.3Other descriptive nameDelamanid
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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)
    E.1.1.1Medical condition in easily understood language
    Pulmonary Multidrug-resistant Tuberculosis (MDR TB)
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10037443
    E.1.2Term Pulmonary tuberculosis, unspecified
    E.1.2System Organ Class 100000004862
    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 evaluate the efficacy of delamanid administered orally as 100 mg twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination
    with optimized background treatment regimen (OBR) versus placebo with OBR.
    E.2.2Secondary objectives of the trial
     •To evaluate the safety of delamanid and placebo as administered in this trial.
     •To evaluate the pharmacokinetics (PK) of delamanid as administered in this trial.
     •To evaluate the development of resistance to delamanid.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Same title as given in Section 1. Version number is "7.1". Sub-trial will be applicable for South Africa only.
    Only sites in South Africa will be eligible and qualified for conducting this clinical trial with HIV co-infected patients.
    E.3Principal inclusion criteria
    1. Provide written, informed consent prior to all trial-related procedures.
    2. Male or female patients aged between 18 and 69 years, inclusive.
    3. Current Diagnosis of MDR TB from one of the following methods:
    • From a single sputum specimen collected no more than 60 days prior to the date of trial enrollment (defined as the date the ICF is signed and screening begins), mycobacterial culture positive for growth of MTB with documented resistance to isoniazid and rifampicin, or
     • From a single sputum specimen collected no more than 60 days prior to date of trial enrollment (defined as the date the ICF is signed and screening begins), either sputum smear positive for acid fast bacilli (AFB) or a rapid test positive for MTB, along with a positive rapid test demonstrating resistance to rifampicin alone, or to rifampicin and isoniazid.
    4. Findings on screening chest radiograph consistent with TB.
    5. Able to produce sputum for mycobacterial culture.
    6. Female patients of childbearing potential must have a negative urine pregnancy test and agree to use a highly effective method of birth control as defined in Section 5.5. .
    7. Male patients must agree to use an adequate method of contraception as defined in Section 5.5.
    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 or use of other anti- arrhythmic drugs for the previous 30 days.
    3. Any current serious concomitant conditions or renal impairment characterized by serum creatinine levels ≥1.5 mg/dL or hepatic impairment characterized by ALT and/or AST levels 3 times the upper limit of the laboratory reference range.
    4. Current clinically relevant abnormalities in the screening ECG including conduction abnormalities (for example, but not limited to, AV block) or QTcF interval over 450 msec in male patients and 470 msec in female patients.
    5. Current clinically relevant/significant cardiovascular disorder such as congestive heart failure, ventricular hypertrophy, coronary artery disease, arrhythmia, or poorly controlled hypertension.
    6. BMI < 16 kg/m2.
    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 currently active clinically significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases (eg, poorly controlled diabetes mellitus), currently active malignancy, or other abnormalities (other than those related to 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 −21 to −2]).
    12. Pregnant, breast-feeding, or planning to conceive or father a child within the timeframe described in the ICF.
    13. Recent use, as determined by urine drug screen, of methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, tetrahydrocannabinol, barbiturates, and opiates which is not
    medically authorized and which in the opinion of the investigator would compromise compliance in the study.
    14. 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.
    15. Previous exposure to delamanid.
    16. Evidence of XDR TB based on the definition from WHO as TB with demonstrated resistance to isoniazid and rifampicin as well to any one of the fluoroquinolones and at least one of three injectable second-line drugs (amikacin, capreomycin, or kanamycin).
    17. HIV co-infection for patients screened at sites not participating in the HIV subtrial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the distribution of the time to SCC using the MGIT system during the 6-month Intensive Treatment Period.
    SCC during the 6-month Intensive Treatment Period is defined as the observation of a sputum specimen negative for growth of MTB using the MGIT culture system, followed by at least one confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive. A confirmed positive is defined as two observed positive results, not taking into account intermittent, missing, or contaminated results. All sputum culture results in between the first negative and confirmatory negative culture 25 days after the first must be negative for growth of MTB. Time to SCC is defined as the interval between the date of the first dose of IMP and the date of collection of the first sputum specimen of 2 consecutive sputum specimens at least 25 days apart that are negative for growth of MTB using the MGIT culture system.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to SCC is defined as the time elapsed between the date of the first dose of delamanid and the date of collection of the first sputum specimen negative for growth of MTB eligible for SCC using the MGIT culture system.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include the following:
     • Proportion of patients with SCC at 2 and 6 months using MGIT and solid culture,
     • Distribution of time to SCC by 6 months using solid culture.
     • Sustained SCC between Month 18 and Month 30, inclusive, using MGIT and solid culture.
     • Treatment outcomes assessed by principal investigators at the end of treatment with OBR (ie, 24 months post randomization).
     • Final outcome at Month 30 as a treatment success or failure (including relapse).
     • Mean change from baseline in TTD using the MGIT system.
     • Mean AUC of change from baseline in time to detection in the MGIT system.
     • Proportion of patients who develop resistance to delamanid.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see section E.5.2
    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 Yes
    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 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. 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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number 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 EEA4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Moldova, Republic of
    South Africa
    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 is defined as the last Date of Contact or the Date of Final Contact Attempt from the Post-treatment Follow-up CRF page for the last patient completing or withdrawing from the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    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 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.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 390
    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)
    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 Decision2011-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-04
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