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    Summary
    EudraCT Number:2015-002969-27
    Sponsor's Protocol Code Number:PMF104PD1-2-3/2013
    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:2015-09-18
    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 number2015-002969-27
    A.3Full title of the trial
    A RANDOMISED, SINGLE-BLIND, ACTIVE CONTROLLED, MULTI-CENTRE TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, ACCEPTABILITY AND PALATABILITY OF PMF104 COMPARED TO A CONVENTIONAL PEG-ELECTROLYTE SOLUTION IN CHILDREN AGED FROM 2 TO LESS THAN 6, FROM 6 TO LESS THAN 12 AND ADOLESCENTS FROM 12 TO LESS THAN 18 YEARS OF AGE REQUIRING A DIAGNOSTIC PROCEDURE CONCERNING THE COLON
    Studio randomizzato, in singolo-cieco, controllato e multicentrico per valutare l’efficacia, la sicurezza, la tollerabilità, l’accettabilità e la palatabilità di PMF104 rispetto ad una convenzionale soluzione elettrolitica di polietilenglicole, somministrate a bambini da 2 a meno di 6 anni, da 6 a meno di 12 anni e ad adolescenti da 12 a meno di 18 anni che necessitano di una procedura diagnostica a livello del colon
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial aimed at evaluating the efficacy, safety, tolerability, acceptability and palatability of PMF104 in children from 2 to less than 18 years old
    Studio clinico che ha l'obiettivo di valutare l'efficacia, la sicurezza, la tollerabilità, l'accettabilità da parte del paziente e la palatabilità del farmaco PMF104 in bambini di età compresa tra i 2 e meno di 18 anni.
    A.4.1Sponsor's protocol code numberPMF104PD1-2-3/2013
    A.5.4Other Identifiers
    Name:CRO-15-125Number:CRO code
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/051/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAlfa Wassermann S.p.A.
    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 supportAlfa Wassermann S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROSS S.A. and associated companies CROSS research S.A. and CROSS Metrics S.A.
    B.5.2Functional name of contact pointOttavia Annoni
    B.5.3 Address:
    B.5.3.1Street AddressVia F.A. Giorgioli 14
    B.5.3.2Town/ cityArzo
    B.5.3.3Post codeCH-6864
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041916300510
    B.5.5Fax number0041916300511
    B.5.6E-mailottavia.annoni@croalliance.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 nameEASYGOL
    D.3.2Product code PMF104
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Nasogastric use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMacrogol 4000
    D.3.9.1CAS number 25322-68-3
    D.3.9.3Other descriptive nameMACROGOL 4000 PH. EUR.
    D.3.9.4EV Substance CodeSUB172298
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number52.500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium sulfate, anhydrous
    D.3.9.1CAS number 7757-82-6
    D.3.9.3Other descriptive nameSODIUM SULPHATE
    D.3.9.4EV Substance CodeSUB20969
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.750
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSimeticone
    D.3.9.1CAS number 8050-81-5
    D.3.9.3Other descriptive nameSIMETICONE
    D.3.9.4EV Substance CodeSUB04403MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.080
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium citrate
    D.3.9.1CAS number 68-04-2
    D.3.9.3Other descriptive nameSODIUM CITRATE ANHYDROUS
    D.3.9.4EV Substance CodeSUB34328
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.863
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCitric acid anhydrous
    D.3.9.1CAS number 77-92-9
    D.3.9.3Other descriptive nameCITRIC ACID ANHYDROUS
    D.3.9.4EV Substance CodeSUB29050
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.813
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.730
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.370
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 KLEAN-PREP
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine Italia S.r.l.
    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 nameKLEAN-PREP
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Nasogastric use (Noncurrent)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Need of bowel cleansing in order to perform a colonoscopy or any other diagnostic or therapeutic procedure concerning the colon.
    Necessità di svuotamento intestinale prima di una colonscopia o di una qualsiasi altra procedure diagnostica o terapeutica concernente il colon.
    E.1.1.1Medical condition in easily understood language
    Bowel cleansing before diagnostic or therapeutic procedures concerning colon.
    Pulizia intestinale prima di una qualsiasi procedura diagnostica o terapeutica concernente il colon.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10071002
    E.1.2Term Rectal cleansing
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PMF104 compared to KLEAN-PREP in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon
    Valutare l'efficacia di PMF104 rispetto a KLEAN-PREP in bambini di età compresa tra 2 e meno di 18 anni con l'indicazione ad effettuare una procedura diagnostica a livello del colon
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to KLEAN-PREP in children aged from 2 to less than 18 years old requiring a diagnostic procedure of the colon
    Valutare l'efficacia, la sicurezza, la tollerabilità, l'accettabilità e la palatabilità di PMF104 rispetto a KLEAN-PREP in bambini di età compresa tra 2 e meno di 18 anni con l'indicazione ad effettuare una procedura diagnostica a livello del colon
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged from 2 to less than 18 years undergoing elective colonoscopy
    2. Female subjects currently either of:
    non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is surgically sterilised via documented hysterectomy or bilateral tubal ligation),
    or
    child bearing potential: the subject is eligible to enter and participate in this study if she is not lactating and has a negative pregnancy test (only menstruated females)
    3. Patients whose parent(s)/legal representative have been thoroughly informed of the aim of the study procedures and provided signed and dated written informed consent
    4. Children aged from 6 to less than 12 years providing informed assent whenever possible
    5. Adolescents aged from 12 to less than 18 years providing informed assent
    6. Ability of the subjects and/or their parents/legal representatives to understand and comply with protocol requirements, instructions and protocol-stated restrictions
    1. Maschi e femmine di età compresa fra 2 e meno di 18 anni con l'indicazione ad effettuare una colonscopia
    2. Femmine non fertili (cioè fisiologicamente incapaci di procreare, incluse femmine sterilizzate chirurgicamente tramite isterectomia o legatura bilaterale delle tube) o, se fertili, non in allattamento e con un test di gravidanza negativo (solo per le pazienti mestruate)
    3. Pazienti il/i cui genitore/i o legale rappresentante sia stato informato riguardo a tutte le procedure di studio e abbia fornito il consenso informato scritto
    4. Bambini di età compresa tra 6 e meno di 12 anni che abbiano fornito l'assenso informato, quando possibile
    5. Adolescenti da 12 a meno di 18 anni che abbiano fornito l'assenso informato
    6. Capacità dei soggetti e/o dei loro genitori/legale rappresentante di comprendere ed attenersi alle richieste, istruzioni e restrizioni previste dal protocollo
    E.4Principal exclusion criteria
    1. Requirement for urgent colonoscopy
    2. Gastrointestinal obstruction or perforation
    3. Bowel pseudo-obstruction
    4. Gastric retention
    5. Toxic colitis
    6. Toxic megacolon
    7. Known or suspected hypersensitivity to the active or other ingredients of both test product and reference product
    8. Clinically significant electrolyte imbalance
    9. Prior intestinal resection
    10. Structural abnormality of the lower gastrointestinal (GI) tract
    11. Known metabolic (particularly phenylketonuria), renal or cardiac disease
    12. Known pregnancy
    13. Subject who have participated in another clinical trial or have taken an investigational drug within the last 3 months prior screening
    1. Indicazione ad una colonscopia urgente
    2. Ostruzione o perforazione gastrointestinale
    3. Pseudo-ostruzione dell'intestino
    4. Ritenzione gastrica
    5. Colite tossica
    6. Megacolon tossico
    7. Ipersensibilità nota o sospetta al principio attivo o agli altri ingredienti del test e del reference
    8. Squilibrio elettrolitico clinicamente significativo
    9. Precedente resezione intestinale
    10. Anomalia strutturale del basso tratto gastrointestinale
    11. Patologie metaboliche (in particolare fenilchetonuria), renali o cardiache
    12. Gravidanza nota
    13. Soggetti che hanno partecipato ad un altro studio clinico o hanno assunto un altro trattamento sperimentale nei tre mesi precedenti lo screening
    E.5 End points
    E.5.1Primary end point(s)
    To compare the efficacy in terms of colon cleansing according the Boston Bowel Preparation Scale (BBPS) score on the day of the diagnostic procedure, to be determinated blindly by the endoscopist upon completion of the examination
    Comparazione dell'efficacia in termini di pulizia del colon, in accordo alla scala di Boston per la preparazione dell'intestino, valutata dall'endoscopista (che effettua la colonscopia in cieco rispetto al trattamento) al termine della colonscopia stessa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Upon completion of the examination
    Al completamento della colonscopia
    E.5.2Secondary end point(s)
    1. Efficacy:
    - Time to reach clear watery stools
    - Proportion of patients in whom caecal intubation was achieved during colonoscopy
    - Proportion of patients achieving a BBPS score grater than or equal to 5
    2. Proportion of patients that needed a rescue dose
    3. Safety assessment
    4. Tolerability assessment
    5. Compliance assessment
    6. Acceptability assessment
    7. Palatability assessment
    1. Efficacia:
    - Tempo necessario per ottenere feci chiare ed acquose
    - Proporzione di pazienti in cui è stata ottenuta l'intubazione cecale
    - Proporzione di pazienti con uno score BBPS maggiore o uguale a 5
    2. Proporzione di pazienti che hanno necessitato di una rescue dose
    3. Valutazione della sicurezza
    4. Valutazione della tollerabilità
    5. Valutazione della compliance
    6. Valutazione dell'accettabilità
    7. Valutazione della palatabilità
    E.5.2.1Timepoint(s) of evaluation of this end point
    During /after the treatment
    Durante/dopo il trattamento
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, acceptability and palatability
    Tollerabilità, accettabilità e palatabilità
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 No
    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
    Ultima visita dell'ultimo paziente
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 430
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 262
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 168
    F.1.2Adults (18-64 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-09-18. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preschool minors
    Minori in età prescolare
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state430
    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
    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 Decision2015-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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