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    Summary
    EudraCT Number:2019-003011-55
    Sponsor's Protocol Code Number:MesaCAPP
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2019-003011-55
    A.3Full title of the trial
    Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
    Programma di prevenzione per il tumore colon-rettale nella sindrome di Lynch (LS) con mesalazina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
    Prevenzione per il tumore colon-rettale nella sindrome di Lynch (LS) con mesalazina
    A.3.2Name or abbreviated title of the trial where available
    MesaCAPP
    MesaCAPP
    A.4.1Sponsor's protocol code numberMesaCAPP
    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 SponsorKarolinska Institutet - Department of Medicine, Solna
    B.1.3.4CountrySweden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlma Mater Studiorum Università di Bologna
    B.5.2Functional name of contact pointDIMEC
    B.5.3 Address:
    B.5.3.1Street AddressVia Massarenti 9
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.6E-mailluigi.ricciardiello@unibo.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 Yes
    D.2.1.1.1Trade name Pentasa Sachet 2 g
    D.2.1.1.2Name of the Marketing Authorisation holderFerring corporate (numero AIC nazionale) 25569
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePENTASA SACHET 2 G
    D.3.2Product code [DK/H/0140/002]
    D.3.4Pharmaceutical form Prolonged-release granules for oral suspension
    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 INN5-ASA (ACIDO-5-AMINOSALICILICO) (MESALAZINA)
    D.3.9.1CAS number 89-57-6
    D.3.9.2Current sponsor codepentasa sachet 2g
    D.3.9.3Other descriptive nameMesalazine
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 placeboGranules for oral suspension
    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
    Lynch syndrome (Hereditary Non-Polyposis Colorectal Cancer)
    Sindrome di Lynch (cancro colorettale ereditario non poliposico)
    E.1.1.1Medical condition in easily understood language
    Lynch syndrome
    Sindrome di Lynch
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10051922
    E.1.2Term Hereditary non-polyposis colorectal cancer syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test whether mesalamine (5-ASA) reduces the occurrence of any colorectal neoplasia (both benign and malignant tumors) compared to placebo in Lynch syndrome (LS) patients as detected by any colonoscopy until the end of treatment (24 months +/- 1 month) and end of study.
    Valutare se Mesalazina (5-ASA) riduce la formazione di neoplasie colon-rettali (sia maligne sia benigne) confrontata con l’utilizzo del placebo in soggetti con sindrome di Lynch (LS) mediante valutazione con colonscopia fino alla fine del trattamento (24 mesi +/- 1) e fino al termine dello studio.
    E.2.2Secondary objectives of the trial
    - To test whether 5-ASA reduces the number of any colorectal neoplasia, both benign and malignant tumors, (tumor multiplicity) and tumor progression to placebo in LS patients at defined time points. Advanced adenomas are defined by a diameter above 1 cm villous or tubulovillous histology or high grade dysplasia.
    - To investigate if differences between 5-ASA effects and placebo effects on the occurrence of colorectal neoplasia, tumor multiplicity or tumor progression depend on the history of colorectal cancer, sex and patients age (LS patients below 45 years of age or 45 years of age and older).
    - To determine the safety concerning 5-ASA in LS patients
    - Valutare se 5-ASA riduce il numero di neoplasie colon-rettali sia benigne sia maligne (molteplicità tumorale) e la progressione tumorale rispetto al placebo in soggetti con LS secondo le tempistiche del protocollo. Gli adenomi in stadio avanzato sono definiti da aspetto villoso o tubulovilloso, diametro superiore a 1 cm o displasia di alto grado.
    - Valutare se le differenze tra gli effetti di 5-ASA e gli effetti del placebo nella comparsa di neoplasia colon-rettale, molteplicità tumorale o progressione tumorale dipenda dalla storia di cancro del colon-retto, dal sesso e dall’età del paziente (pazienti con LS al di sotto dei 45 anni di età o al sopra dei 45 anni di età).
    - Valutare la sicurezza dell’utilizzo di 5-ASA in soggetti con LS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Proven tumor-free (including patients in which the polyps are removed endoscopically) carriers of a germline pathologic mutation on one of the MMR genes including MLH1, MSH2 (including EpCAM) and MSH6
    • Male or female subjects with the age > 30 years
    • Females who have been post-menopausal more than one (1) year or females of childbearing potential using a highly efficient method of contraception with less than 1% failure rate (i.e. oral hormonal contraceptives, hormone implants, hormone injections, sterilization, hormonal or copper intrauterine device, sterilized/vasectomized partner, or diaphragm in combination with a condom, spermicide or birth control pills) or should agree to abstain from heterosexual activity during treatment period.
    Females of childbearing potential must have a negative pregnancy test at screening and randomization.
    • Signed written informed consent prior to inclusion in the study
    - Comprovata assenza di tumore (compresi i pazienti in cui sono presenti i polipi rimossi endoscopicamente) in portatori di una mutazione germinale patologica in uno dei geni MMR, inclusi MLH1, MSH2 (comprensivo di EpCAM) e MSH6.
    - Soggetti di sesso maschile e femminile con età >30 anni.
    - I soggetti di sesso femminile in menopausa da almeno 1 anno oppure in età fertile devono utilizzare un metodo contraccettivo con alta efficacia con % di fallimento inferiore a 1% (es. contraccettivi ormonali orali, impianto ormonale, iniezioni ormonali, sterilizzazione, device intrauterino ormonale o al rame oppure con partner sottoposti a vasectomia o sterilizzazione oppure diaframma in combinazione con condom, spermicida o pillola per il controllo delle nascite) oppure dovrebbero dichiarare l’astensione da attività eterosessuale durante il periodo del trattamento. Le donne in età fertile devono presentare un test di gravidanza negativo alla visita di screening e di randomizzazione.
    - Essere in grado di comprendere e firmare un modulo di consenso informato scritto, che deve essere consegnato prima dell’inizio delle procedure di studio.
    E.4Principal exclusion criteria
    • Presence of colorectal endoscopically non-removable benign neoplasia (patient can be included if the adenoma is removed)
    • Carriers of germline mutations in PMS2
    • Patients with history of stage 3 and 4 colorectal cancer (CRC)
    • Presence of any metastatic disease
    • Regular use of acetylsalicylic acid (ASA or aspirin): daily use of =100mg in more than 3 continuous months within the last year
    • Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year
    • Hypersensitivity to 5-ASA
    • Patients after any subtotal or total colectomy
    • Colorectal surgery within the previous 6 months
    • Unwillingness to participate or who is considered unable to give an informed consent
    • Pregnant or breastfeeding women
    • Participation in another clinical study investigating another IMP within 3 months prior to screening
    • Renal insufficiency (GFR <30ml/min/1.73m2)
    • Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)
    • Current or history of serious psychiatric disorder or alcohol/drug abuse that in the opinion of the investigator may impact the assessment of IMP safety and efficacy or protocol adherence
    • Prior history of myocarditis or pericarditis. Other severe acute or chronic medical condition (such as severe chronic lung (COPD, including asthma), kidney or heart diseases), duodenal ulcer, haemorrhagic diathesis or psychiatric condition or other abnormal clinical sign or laboratory abnormality that may increase the risk associated with study participation or ability to comply with study procedures, IMP administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
    - Presenza di neoplasia benigna colon-rettale endoscopicamente non asportabile (il paziente può essere incluso se l'adenoma viene rimosso)
    - Portatori di mutazioni germinali in PMS2.
    - Pazienti con storia clinica di cancro colon-rettale (CRC) di stadio 3 o 4.
    - Presenza di qualsiasi malattia metastatica.
    - Uso regolare di Acido acetilsalicilico (ASA o aspirina): utilizzo quotidiano =100 mg per più di 3 mesi continuativi nell’ultimo anno.
    - Utilizzo regolare di FANS o inibitori COX-2: utilizzo quotidiano per più di 3 mesi continuativi nell’ultimo anno.
    - Ipersensibilità a 5-ASA.
    - Soggetti sottoposti a precedente colectomia totale o subtotale.
    - Soggetti che hanno subito interventi chirurgici colon-rettali nei 6 mesi precedenti.
    - Soggetti incapaci a partecipare o considerati incapaci di fornire un consenso informato.
    - Donne in gravidanza o in stato di allattamento.
    - Soggetti inclusi in un altro protocollo clinico comprensivo di terapia medica sperimentale nei 3 mesi precedenti lo screening.
    - Presenza di insufficienza renale (GFR <30ml/min/1.73m 2 )
    - Severa malattia epatica (enzimi epatici >3x ULN)
    - Presenza o storia di importanti disturbi psichiatrici o utilizzo di alcool e droghe che secondo l’opinione dello sperimentatore possono interferire con la valutazione della sicurezza e l’efficacia del trattamento di studio e con l’aderenza alle procedure del protocollo.
    - Storia clinica di miocarditi o pericarditi. Altre condizioni cliniche acute o croniche come patologie croniche severe (polmonari come BPCO, incluso asma, renali, cardiache), ulcera duodenale, diatesi emorragica, o condizioni psichiatriche o altre condizioni cliniche o anomalie di laboratorio che possono aumentare il rischio associato alla partecipazione allo studio o alla capacità di aderire alle procedure dello studio, alla somministrazione dell’ IMP e, a giudizio dello sperimentatore, renderebbero il soggetto inappropriato per l'inserimento nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of any colorectal neoplasia (both benign and malignant tumors) between groups is described by absolute frequencies and percentages with 95 % confidence intervals.
    A logistic regression is used to assess differences between active treatment and placebo for the occurrence of any colorectal neoplasia, adjusted for country and history of cancer before randomization. Treatment effects are assessed by odds-ratios and corresponding 95 % confidence intervals.
    La comparsa di qualsiasi neoplasia colon-rettale sia benigna che maligna tra gruppi è descritto da frequenze assolute e percentuali con intervalli di confidenza al 95%.
    Un test di regressione logistica è utilizzato per valutare le differenze tra il trattamento attivo e il placebo per l'insorgenza di qualsiasi neoplasia del colon-retto, adattato per paese e storia di cancro prima della randomizzazione. Gli effetti del trattamento sono valutati da odds-ratio e da corrispondenti intervalli di confidenza al 95%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits at 3, 12, 24 months. Conoscopy annually or every two years, and at the end of treatment (24 month +/- 1 month)
    Visite a 3, 12, 24 mesi. Colonscopia annuale o ogni 2 anni, e al termine dello studio (24 mesi +/- 1 mese)
    E.5.2Secondary end point(s)
    • The number of colorectal neoplasia (both benign and malignant tumors)per patient will be tested between groups by an analysis of variance, adjusting for country and history of cancer before randomization. In case of non-normally distributed residuals a suitable transformation to achieve normal distribution is considered.
    • The tumor progress in the 4 ordered stages will be tested between groups by a chi-square trend test stratified for country and history of cancer before randomization and modelled by an ordinal logistic regression.
    • The dependence of treatment effects on history of colorectal cancer, sex and patients age (<45 years and =45 years) will be assessed by modelling interactions between these factors and treatment in the corresponding regression models.
    • Safety data are described and compared between groups in an exploratory manner.
    All tests are two-sided and a significance level of 5 % is used.
    Il numero di neoplasie colon-rettali sia benigne che maligne per ogni paziente sarà calcolato tra i gruppi mediante un'analisi di varianza, mediante correzione per paese e storia di cancro prima della randomizzazione. In caso di variabili residue non distribuite normalmente verrà considerata una trasformazione adatta a raggiungere una distribuzione normale.
    La progressione del tumore nei 4 stadi verrà valutata mediante test di del chi quadrato stratificato per paese e storia del cancro prima della randomizzazione e adattato da un test di regressione logistica ordinale.
    Gli effetti del trattamento sulla storia del cancro del colon-retto, il sesso e l’età dei pazienti (<45 anni e =45 anni) saranno valutati adattando le interazioni tra questi fattori e il trattamento nei corrispondenti modelli di regressione.
    I dati di sicurezza sono descritti e confrontati tra i gruppi in maniera esplorativa.
    Tutti i test sono bilaterali e sarà utilizzato un livello di significatività del 5%.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See primary endpoints
    Gli stessi degli endpoint primari
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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
    Israel
    Poland
    Sweden
    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. 4 years after the end of treatment a Phone Follow-up visit is planned to collect all colonoscopy data and analyze the longterm effect of 2-years treatment with 5-ASA.
    LVLS. Dopo 4 anni dal termine del trattamento è prevista una visita di follow-up telefonica pianificata per raccogliere tutti i dati della colonscopia e analizzare l’effetto a lungo termine del trattamento di 2 anni con 5-ASA.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 160
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 260
    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)
    Regular colonscopies according to clinical practice
    I pazienti continueranno ad effettuare colonscopie in base alle singole necessità per individuare la formazione di eventuali nuovi polipi colon-rettali e la loro rimozione, secondo pratica clinica.
    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 Decision2023-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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