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    Summary
    EudraCT Number:2011-004765-32
    Sponsor's Protocol Code Number:ST261-DM-11-005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-07-23
    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 number2011-004765-32
    A.3Full title of the trial
    Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment.
    Studio di Fase III, a gruppi paralleli, controllato con placebo, in doppio cieco, randomizzato, multicentrico, internazionale per valutare la sicurezza e l'efficacia di ST261 (propionil-L-carnitina cloridrato) compresse a rilascio modificato in pazienti affetti da colite ulcerosa lieve che seguono stabilmente il trattamento orale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates
    Ricerca dei potenziali effetti collaterali ed effetti sull'intestino crasso del propionil-L-carnitina cloridrato (ST261)(dato in compresse che rilasciano il principio attivo solo nell'intestion crasso) in pazienti con colite ulcerosa lieve che sono tratati in comcomitantza con dosi stabili di aminosalicilati
    A.3.2Name or abbreviated title of the trial where available
    Propionyl-L-Carnitine in Ulcerative Colitis
    Propionil-L-Carnitina nelle Coliti Ulcerose
    A.4.1Sponsor's protocol code numberST261-DM-11-005
    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 SponsorSIGMA-TAU
    B.1.3.4CountryItaly
    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 supportSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.5.2Functional name of contact pointCucco Carla
    B.5.3 Address:
    B.5.3.1Street AddressVia Pontina Km 30.400
    B.5.3.2Town/ cityPomezia (Rome)
    B.5.3.3Post code00040
    B.5.3.4CountryItaly
    B.5.4Telephone number06-91394322
    B.5.5Fax number06-91166976
    B.5.6E-mailcarla.cucco@sigma-tau.it
    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 namePROPIONYL L-CARNITINE
    D.3.2Product code ST 261
    D.3.4Pharmaceutical form Prolonged-release 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 INNLevocarnitine propyl hydrochloride
    D.3.9.1CAS number 119793-66-7
    D.3.9.2Current sponsor code(ST261) Propionyl-L-carnitine
    D.3.9.3Other descriptive name(R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number500
    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 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 placeboProlonged-release tablet
    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
    Mild ulcerative colitis
    COlite ulcerosa lieve
    E.1.1.1Medical condition in easily understood language
    mild non-infectious inflammation of the large bowel
    Infiammazione lieve non infettiva dell'intestino crasso
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the two treatment groups (ST 261 modified release tablets 1g/die vs. placebo) with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment Evaluation of safety and tolerability of ST 261
    confrontare i due gruppi di trattamento (propionil-L-carnitina cloridrato, ST 261, compresse a rilascio modificato 1g/die rispetto al placebo) relativamente alla proporzione di pazienti con remissione della malattia alla fine delle 8 settimane di trattamento.Valutazione della sicurezza e della tollerabilità di ST 261
    E.2.2Secondary objectives of the trial
    Maintenance of remission after four weeks of treatment interruption, the histological changes, the disease symptoms (sub-scores) improvement and the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
    mantenimento della remissione dopo quattro settimane di interruzione del trattamento,i cambiamenti istologici,il miglioramento dei sintomi della malattia (sottopunteggi) e la qualità della vita in generale secondo lo Short Inflammatory Bowel Disease Questionnaire (Questionario breve sulla malattia infiammatoria intestinale,SIBDQ)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have read the Information for the Patient and signed the Informed Consent Form. 2. Age comprised between 18 and 75 included. 3. Diagnosis of active ulcerative colitis since at least 4 weeks as confirmed endoscopically (pancolonoscopy) and histologically. A new pancolonoscopy is required if documented evidence of having performed it within the previous 12 months is not available. If available, only a new colonoscopy for the visualization of the affected part of the colon is required for the evaluation of the baseline DAI score. 4. Disease Activity Index comprised between 3 and 6, inclusive (mild ulcerative colitis), with rectal bleeding sub-score of at least 1. 5. Stable background oral aminosalycilates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments. 6. If female, not pregnant or nursing. 7. For women of childbearing potential (WOCBP), willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug. A WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral ovariectomy) or is not postmenopausal (defined as amenorrhoea >12 consecutive months). WOCBP should use an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication. They must be on a stable regimen, for at least 1 month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, intrauterine device (IUD), condom and spermicidal agent, or diaphragm and spermicidal agent.The patient will be informed about the results of the pregnancy test and of the allowed method of contraception and its duration
    1. hanno letto le Informazioni per il paziente e firmato il Modulo di consenso informato; 2. età compresa tra 18 e 75 anni inclusi; 3. diagnosi di colite ulcerosa attiva da almeno 4 settimane confermata con endoscopia (pancolonscopia) e istologicamente. Laddove non sia disponibile una prova documentale dell’esecuzione di una pancolonscopia relativa agli ultimi 12 mesi, sarà necessario eseguirne una nuova. Se disponibile, è necessaria solo una nuova colonscopia per la visualizzazione della parte interessata del colon, ai fini della valutazione del punteggio DAI al basale; 4. un Indice di attività della malattia (DAI) compreso tra 3 e 6, inclusi, (colite ulcerosa lieve) con sottopunteggio di sanguinamento rettale pari almeno a 1; 5. hanno seguito stabilmente una terapia di base con aminosalicilati orali (mesalazina, balsalazide, olsalazina) oppure la terapia standard con sulfasalazina per almeno 4 settimane prima delle valutazioni di screening; 6. se di sesso femminile, non sono in gravidanza o allattamento; 7. per le donne potenzialmente fertili (Women of childbearing potential, WOCBP), disponibilità a evitare una gravidanza durante il periodo di trattamento e per almeno 4 settimane dall’ultima dose del farmaco. Una donna potenzialmente fertile (WOCBP) viene definita come un soggetto di sesso femminile che abbia avuto il menarca e non si sia sottoposta a riuscita sterilizzazione chirurgica (isterectomia, occlusione bilaterale delle tube oppure ovariectomia bilaterale) o non sia in postmenopausa (definita come amenorrea &gt;12 mesi consecutivi). Una donna potenzialmente fertile (WOCBP) deve utilizzare un metodo contraccettivo efficace per l’intera durata della sperimentazione e fino alle prime mestruazioni dopo un periodo di 30 giorni dall’ultima dose del farmaco sperimentale. Devono seguire un regime stabile, da almeno 1 mese, di contraccettivi orali, impianto contraccettivo o iniezione a deposito, cerotto contraccettivo, dispositivo intrauterino (IUD), preservativo e agente spermicida, oppure diaframma e agente spermicida.La paziente sarà informata sui risultati del test di gravidanza e sui metodi contraccettivi permessi e la loro durata.
    E.4Principal exclusion criteria
    1. Crohn's disease and indeterminate colitis. 2. Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids. 3. Use of systemic antibiotics in the last 10 days preceding the screening. 4. Use of systemic NSAIDs on a repeat basis in the last 10 days preceding the screening. 5. Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study. 6. Use of immunosuppressants or biological agents within the last 6 weeks preceding the screening. 7. Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile). 8. Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator. 9. History of colon resection. 10. Diverticulitis, symptomatic diverticulosis. 11. Active peptic ulcer disease. 12. Proctitis (extent of inflammation <15 cm from the anus). 13. Bleeding disorders 14. Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening. 15. Active or chronic infection(s) or malignancies. 16. Known hypersensitivity to the active ingredient and excipients of the study drug. 17. Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study. 18. Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance 19.Patients treated with L-carnitine or its esters derivatives during the three months preceding the screening.
    1. morbo di Crohn e colite indeterminata; 2. attuale o precedente utilizzo (negli ultimi 10 giorni precedenti lo screening) di corticosteroidi sistemici; 3. uso di antibiotici sistemici negli ultimi 10 giorni precedenti lo screening; 4. uso ripetuto di FANS sistemici negli ultimi 10 giorni precedenti lo screening; 5. uso di probiotici iniziati nei 10 giorni precedenti lo screening. Un regime stabile da almeno 10 giorni precedenti lo screening è consentito, ma il paziente deve essere disposto a continuare fino alla fine dello studio; 6. uso di immunosoppressori o agenti biologici entro le ultime 6 settimane precedenti lo screening; 7. coltura delle feci positiva agli enteropatogeni (ad es. Shigella, Salmonella, Yersinia, Campylobacter) o alle tossine (C. difficile); 8. funzione epatica, renale, polmonare o cardiovascolare notevolmente compromessa in base al giudizio dello sperimentatore; 9. anamnesi di resezione del colon; 10. diverticolite, diverticolite sintomatica; 11. ulcera peptica attiva; 12. proctite (estensione dell’infiammazione &lt; 15 cm dall’ano); 13. disturbi emorragici; 14. terapia rettale con clisteri o supposte terapeutici, con l’eccezione di quelli richiesti per l’endoscopia, durante i 10 giorni precedenti lo screening; 15. infezione cronica attiva o neoplasie maligne; 16. nota ipersensibilità al principio attivo e agli eccipienti del farmaco in studio; 17. partecipazione simultanea a un’altra sperimentazione clinica, o partecipazione a una sperimentazione clinica che prevede l’uso di farmaci sperimentali entro 3 mesi dall’arruolamento al presente studio; 18. una patologia fisica o psicologica del paziente che porti lo sperimentatore a sospettare la sua scarsa compliance 19.Pazienti trattati con L-carnitina o sue derivazioni estere durante i tre mesi precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the clinical/endoscopic remission defined as a Disease Activity Index at the end of treatment ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1.
    L’endpoint primario sarà la remissione clinica/endoscopica definita come un Indice di attività della malattia alla fine del trattamento (punteggio DAI) ≤ 2 con sottopunteggio di emorragia rettale = 0 e nessun altro singolo sottopunteggio > 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease Activity Index at the end of treatment ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score > 1.
    Indice di attività della malattia alla fine del trattamento (punteggio DAI) ≤ 2 con sottopunteggio di emorragia rettale = 0 e nessun altro singolo sottopunteggio > 1
    E.5.2Secondary end point(s)
    • Rectal bleeding evaluation by means of DAI sub-score (from 0 to 3). • Stool frequency evaluation by means of DAI sub-score (from 0 to 3). A clinical response for each of these parameters is defined as a subscore improvement of at least 1 point over baseline. The histological response to the treatments, defined as an improvement of the Histological Index (HI – see Appendix III) of at least 1 point at the end of the study (a final HI score of ≤1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point. The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers. A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients' Quality of Life. The safety and tolerability of the treatments will be investigated through AEs recording, vital signs, ECG and laboratory evaluation.
    - valutazione dell’emorragia rettale attraverso il sottopunteggio DAI (da 0 a 3); - valutazione della frequenza evacuativa attraverso il sottopunteggio DAI (da 0 a 3); Una risposta clinica per ciascuno di questi parametri viene definita come un miglioramento del sottopunteggio di almeno 1 punto rispetto al basale. Inoltre, la risposta istologica ai trattamenti, definita come un miglioramento dell’Indice istologico (Histological Index, HI) di almeno 1 punto alla fine dello studio (un punteggio HI finale pari a 1 sarà definito come una remissione istologica) sarà valutata con endpoint esplorativo aggiuntivo. La proteina C-reattiva e il fibrinogeno sierici saranno monitorati per esaminare la possibile correlazione tra l’esito clinico/endoscopico e il livello sierico di questi marcatori infiammatori. Uno specifico questionario validato (Short Inflammatory Bowel Disease Questionnaire, SIBDQ, della McMaster University) sarà dispensato per valutare i cambiamenti nella qualità della vita dei pazienti. La sicurezza e la tollerabilità dei trattamenti saranno esaminate attraverso la registrazione di EA, segni vitali, ECG e valutazioni di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    A clinical response for each of these parameters is defined as a subscore improvement of at least 1 point over baseline. The histological response to the treatments, defined as an improvement of the Histological Index (HI – see Appendix III) of at least 1 point at the end of the study (a final HI score of ≤1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point. The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers. A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients'
    La risposta clinica per ciascuno di questi parametri viene definita come miglioramento del sottopunteggio di almeno 1 punto rispetto al basale la risposta istologica ai trattamenti, definita come miglioramento dell’Indice istologico(Histological Index,HI)di almeno 1 punto alla fine dello studio(un punteggio HI finale < o = a 1 sarà definito come una remissione istologica)sarà valutata con endpoint esplorativo aggiuntivo.La proteina C-reattiva e il fibrinogeno sierici saranno monitorati per esaminare la possibile correlazione tra l’esito clinico/endoscopico e il livello sierico di questi marcatori infiammatori.Uno specifico questionario validato(Short Inflammatory Bowel Disease Questionnaire, SIBDQ, della McMaster University) sarà dispensato per valutare i cambiamenti nei paz
    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.7.1.3.1Other 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    LVLS
    LVLS
    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 months21
    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 months21
    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: 400
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    No
    Nessuno
    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 Decision2012-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-07-05
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