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    Summary
    EudraCT Number:2010-022439-12
    Sponsor's Protocol Code Number:ATH008-CLN02
    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:2012-12-11
    Trial 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 number2010-022439-12
    A.3Full title of the trial
    A phase II Placebo Controlled; Multicenter Study to Investigate the Safety and Efficacy of ATH008 cream in Patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy.
    Studio multicentrico di fase II, controllato rispetto a placebo, per la valutazione della sicurezza ed efficacia della crema ATH008 in pazienti con sindrome di eritrodisestesia palmo-plantare (PPES), secondaria a terapia con capecitabina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter study, placebo controlled, to investigate safety and efficacy of ATH008 cream in patients with Palmar-Plantar Erythrodysesthesia Syndrome (PPES) secondary to capecitabine therapy.
    Studio multicentrico, controllato rispetto a placebo, per valutare la sicurezza e l'efficacia della crema ATH008 in pazienti con sindrome mano-piede secondaria alla terapia con capecitabina.
    A.4.1Sponsor's protocol code numberATH008-CLN02
    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 SponsorADVANCELL
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportADVANCELL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROMSOURCE S.R.L.
    B.5.2Functional name of contact pointMONICA FIORE
    B.5.3 Address:
    B.5.3.1Street AddressVIA SCUDERLANDO 10
    B.5.3.2Town/ cityVERONA
    B.5.3.3Post code37135
    B.5.3.4CountryItaly
    B.5.4Telephone number0458222811
    B.5.5Fax number0458222812
    B.5.6E-mailath008cromsourceteam@cromsource.com
    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 nameATH008 CREAM
    D.3.2Product code NA
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinolo
    D.3.9.1CAS number 315-30-0
    D.3.9.2Current sponsor code1212
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeIpoxantina analoga
    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 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 nameATH008 CREAM
    D.3.2Product code NA
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinolo
    D.3.9.1CAS number 315-30-0
    D.3.9.2Current sponsor code1212
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeIPOXANTINA ANALOGA
    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 placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Palmar-Plantar Erythrodysesthesia Syndrome (PPES)
    Sindrome di Eritrodisestesia palmo-plantare (PPES)
    E.1.1.1Medical condition in easily understood language
    Hand-foot syndrom caused by chemotherapy
    Sindrome mano-piede causata dalla chemioterapia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054524
    E.1.2Term Palmar-plantar erythrodysesthesia syndrome
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study Part II – Safety and Primary Efficacy evaluation • To demonstrate the safety of ATH008 cream in subjects presenting PPES secondary to capecitabine therapy. • To demonstrate the efficacy of ATH008 cream in reducing the number of subjects presenting PPES grade 2/3 secondary to capecitabine therapy.
    Parte II dello Studio – Valutazione della sicurezza e dell’efficacia primaria • Dimostrare la sicurezza della crema ATH008 in soggetti presentanti PPES secondaria alla terapia con capecitabina • Dimostrare l’efficacia della crema ATH008 nel ridurre il numero di soggetti presentanti PPES di grado 2/3 secondaria alla terapia con capecitabina.
    E.2.2Secondary objectives of the trial
    Study Part II – Secondary Safety and Efficacy evaluation • To determine the plasmatic levels of the active ingredient, allopurinol, and its metabolite, oxypurinol, when given topically. • To demonstrate the efficacy of ATH008 cream in improving the quality of life of subjects presenting PPES. • To demonstrate the efficacy of ATH008 cream in improving the signs and symptoms of PPES. Exploratory Objectives Part II • To describe the accumulated dose intensity of capecitabine before and during ATH008 cream treatment in order to find any possible correlation between the efficacy of the product and the accumulated dose intensity before development of PPES grade 2 or 3.
    Parte II dello Studio – Valutazione della sicurezza e dell’efficacia secondaria • Determinare i livelli plasmatici del componente attivo, allopurinolo, e del suo metabolita, ossipurinolo, quando somministrato per via topica • Dimostrare l’efficacia della crema ATH008 nel migliorare la qualità della vita dei soggetti affetti da PPES • Dimostrare l’efficacia della crema ATH008 nel migliorare i segni e i sintomi della PPES. Obiettivi esplorativi Parte II • Descrivere la concentrazione di capecitabina accumulata prima e durante il trattamento con la crema ATH008 al fine di identificare qualsiasi possibile correlazione tra l’efficacia del prodotto e la concentrazione della dose accumulata prima dello sviluppo della PPES di grado 2 o 3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have signed Informed Consent. • Are under capecitabine therapy for treatment of colon or breast cancer at a regimen of 2 weeks on and 1 week off (14+7) and a daily doses between 2000 and 2500 mg/m2. • Diagnosis of PPES grade 1 in any hand or foot according to the NCI CTCAE v4.03 definition (Appendix 20.1). • Are able to apply topical medication or provide for another person to apply it. • Have a life expectancy longer than 3 months. • In Part I, subjects still have to undergo at least 1 planned cycle with capecitabine monotherapy. • In Part II, subjects still have to undergo at least 2 planned cycles with capecitabine therapy.
    • Avere firmato il Consenso Informato • Essere in trattamento con capecitabina per il trattamento del tumore al colon o al seno ad un regime di due settimane e 1 settimana di riposo (14+7) e una dose giornaliera compresa tra i 2000 e i 2500 mg/m2 • Diagnosi di PPES di grado 1 su mano o piede in accordo alla definizione del NCI CTCAE v4.03 (appendice 20.1) • Il soggetto è in grado di applicare farmaci topici o ha a disposizione un'altra persona per l’applicazione • Ha un’aspettativa di vita maggiore di 3 mesi • Nella Parte I, i soggetti devono ancora sottostare ad almeno 1 ciclo pianificato di monoterapia con capecitabina • Nella Parte II, I soggetti devono ancora sottostare ad almeno 2 cicli pianificati di terapia con capecitabina
    E.4Principal exclusion criteria
    • Are younger than 18 years. • Use of other chemotherapies for the treatment of cancer except trastuzumab (Herceptin) or bevacizumab (Avastin). • Diagnosis of PPES grade 1 in any hand or foot according to the NCI CTCAE v4.03 definition (Appendix 20.1) for more than 2 cycles previously to inclusion in this clinical study. • Haematological limits indicating that capecitabine (Xeloda) cannot be administered due to safety reasons, based on the PI review before each cycle of chemotherapy. • Total bilirubin > 3 upper normal value. • Serum creatinine level > 2 upper normal value. • Have neurologic symptoms greater than grade 1, which under the criteria of the clinician could interfere with PPES diagnosis or study treatment (e.g. hands or feet neuropathy). • Have any dermatologic condition that in the opinion of the investigator may affect hands or feet or may complicate evaluation during study treatment (e.g. neurodermatitis, psoriasis, etc). • Have onycholysis with a non-stable grade 1 or onycholysis greater than grade 1 (nail loss, NCI CTCAE v4.03 criteria) which in the assessment of the clinician could interfere with PPES diagnosis or study treatment. • Need to use other emollient creams or other topical treatments in hands and/or feet during the study. • Are receiving radiotherapy. • Are actively treated with systemic allopurinol (oral or parenteral) for the treatment of gout, or any other indication. • Have developed a severe reaction to allopurinol in the past (e.g. Lyell syndrome). • Known allergy to allopurinol or any of the excipients of the product. • Previous contraindication to treatment with capecitabine. • Have received topical corticosteroids in hands or feet 7 days prior to planned inclusion in the study. • Are participating in any other investigational studies for the treatment of PPES. • Have participated in any other investigational studies for the treatment of PPES, or received an experimental therapeutic procedure, considered to potentially interfere with the study in the 4 weeks preceding Day 1. • Have a serious medical or psychiatric condition that could, in the investigator’s opinion, potentially interfere with their study treatment or participation in the study. • Pregnant women, women in child bearing age not using contraceptives or men not using contraceptives. Methods of contraception which have a failure rate (Pearl index) of less than 1 per cent per year are regarded as highly effective. • Are participating in other clinical trials.
    • Eta’ inferiore a 18 anni. • L’uso di altri chemioterapici per il trattamento del tumore eccetto per trastuzumab (Herceptin) o bavacizumab (Avastin). • Diagnosi di PPES di grado 1 su mano o piede in accordo alla definizione NCI CTCAE v4.03 (appendice 20.1) per più di due cicli precedentemente all’inclusione in questo studio clinico • Revisione dei limiti ematologici indicanti che la capecitabina (Xeloda) non può essere somministrata per ragioni di sicurezza, eseguita del PI prima di ogni ciclo di chemioterapia • Bilirubina totale &gt; 3 volte il limite normale superiore Livello di creatinina sierica &gt; 2 volte il limite normale superiore • Avere sintomi neurologici superiori al grado 1, che in base ai criteri del clinico potrebbero interferire con la diagnosi o il trattamento della PPES o il trattamento in studio (ad esempio neuropatia delle mani o dei piedi) • Avere qualsiasi condizione dermatologica che secondo l’opinione dello sperimentatore possa avere effetto sulle mani o sui piedi o possa complicare la valutazione del trattamento in studio (per esempio neurodermatite, psoriasi, etc..) • Avere onicolisi con grado 1 non-stabile o onicolisi superiore al grado 1 (perdita delle unghie, criteri NCI CTCAE V4.03) che nella valutazione del medico potrebbe interferire con la diagnosi di PPES o il trattamento in studio • Necessità di usare altre creme emollienti o altri trattamenti topici sulle mani e/o piedi durante lo studio • Si sta ricevendo radioterapia • Essere trattati attivamente con allopurinolo sistemico (orale o parentale) per il trattamento della gotta, o per qualsiasi altra indicazione • Avere sviluppato una grave reazione all’allopurinolo in passato (per esempio syndrome Lyell) • Allergia accertata all’allopurinolo o a qualsiasi altro eccipiente del prodotto • Precedente controindicazione al trattamento con capecitabina • Avere ricevuto corticosteroidi topici sulle mani o sui piedi 7 giorni prima dell’inclusione pianificata nello studio • Essere inclusi in qualsiasi altro studio per il trattamento della PPES • Aver partecipato a qualsiasi altro studio per il trattamento della PPES, o aver ricevuto una procedura sperimentale terapeutica nelle 4 settimane precedenti il Giorno 1, che potenzialmente possa interferire con lo studio. • Avere una condizione medica psichiatrica seria che possa, nell’opinione dello sperimentatore, potenzialmente interferire con il trattamento in studio o con la partecipazione allo studio. • Donne in gravidanza, donne potenzialmente gravide che non usino contraccettivi o uomini che non usino contraccettivi. Metodi di contraccezione che hanno una percentuale di fallimento (indice di Pearl) minore dell’1 per cento all’anno sono considerati altamente efficaci. • Essere inclusi in altri studi clinici.
    E.5 End points
    E.5.1Primary end point(s)
    Study Part II Safety variables: adverse events and serious adverse events (incidence, causality, and severity) related to treatment with ATH008 cream Pharmacokinetic variables:plasmatic allopurinol levels; plasmatic oxypurinol levels Primary efficacy variable: percentage of subjects that develop PPES grade 2 or 3 according to the NCI CTCAE v4.03 criteria
    Studio Parte II Variabili di sicurezza: eventi avversi ed eventi avversi gravi (incidenza, causalità, gravità), correlati al trattamento con crema ATH008 Variabili farmacocinetiche:livelli plasmatici di allopurinolo; livelli plasmatici di ossipurinolo Variabile Primaria di Efficacia: percentuale di soggetti che sviluppano PPES di grado 2 o 3 secondo i criteri CTCAE NCI V4.03
    E.5.1.1Timepoint(s) of evaluation of this end point
    VO, V1(1-5th day of capecitabine cycle), V2 (D21+-3),V3 (D42+-3),V4 (D63 +-3) and V5(1st day of next capecitabine cycle)
    VO, V1(1°-5°giorno del ciclo di capecitabina), V2 (D21+-3),V3 (D42+-3),V4 (D63 +-3) and V5(1° giorno del successivo ciclo di capecitabina)
    E.5.2Secondary end point(s)
    Efficacy evaluation: - todemonstrate the efficacy of ATH008 cream in improving the quality of life of patients presenting PPES -to demonstrate the efficacy of ATH008 cream in improving the signs and symptoms of PPES Exploratory objectives: - to describe the accumulated dose intensity of capecitabine before and during treatment in order to find any possible correlation between the efficacy of the product and the accumulated dose intensity before development of PPES grade 2 or 3.
    Valutazione dell'efficacia: - dimostrare l'efficacia della crema ATH008 per migliorare la qualità della vita dei pazienti che presentano PPES - dimostrare l'efficacia della crema ATH008 nel migliorare i segni ed i sintomi della PPES Obiettivi esplorativi: - descrivere la dose di capecitabina accumulata prima e durante il trattamento per trovare un'eventuale correlazione tra l'efficacia del prodotto e la dose di capecitabina accumulata prima dello sviluppo di PPES di grado 2 o 3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    VO, V1(1-5th day of capecitabine cycle), V2 (D21+-3),V3 (D42+-3),V4 (D63 +-3) and V5(1st day of next capecitabine cycle)
    VO, V1(1°-5°giorno del ciclo di capecitabina), V2 (D21+-3),V3 (D42+-3),V4 (D63 +-3) and V5(1° giorno del successivo ciclo di capecitabina)
    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 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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV: phone call for visit 6
    LSLV: contatto telefonico previsto per la visita 6
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    E.8.9.2In all countries concerned by the trial months20
    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.1.1Number of subjects for this age range: 0
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 114
    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)
    Subject will be allowed to continue with tha ATH008 cream treatment and will be followed up separately until the end of capecitabine therapy or evolution of PPES to grade 2 or 3.
    Al paziente sarà data la possibilità di continuare il trattamento con la crema ATH008 e in tal caso sarà seguito (separatamente) fino alla fine della terapia con capecitabina o all'evoluzione della PPES di grado 2 o 3.
    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 Decision2012-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-14
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