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    Summary
    EudraCT Number:2013-001620-20
    Sponsor's Protocol Code Number:CF13.01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-001620-20
    A.3Full title of the trial
    Randomized, multicentre, single blind study to evaluate the effectiveness of two administration schedules of CitraFleet (sodium picosulfate plus magnesium citrate) to cleanse the colon
    Randomisierte, multizentrische, einfach verblindete Studie zur Untersuchung der Wirksamkeit zweier Verabreichungsschemata von CitraFleet (Natriumpicosulfat plus Magnesiumcitrat) zur Reinigung des Dickdarms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical trial to evaluate the effectiveness of two administration schedules of CitraFleet to cleanse the colon
    A.4.1Sponsor's protocol code numberCF13.01
    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 SponsorLaboratorios Casen-Fleet S.L.U.
    B.1.3.4CountrySpain
    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 supportLaboratorios Casen-Fleet S.L.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApices para Laboratorios Casen-Fleet S.L.U.
    B.5.2Functional name of contact pointAngel Callejo Mellén
    B.5.3 Address:
    B.5.3.1Street AddressVia de las Dos Castillas, 33,3 Atica, Edificio 7
    B.5.3.2Town/ cityPozuelo De Alarcón (Madrid)
    B.5.3.3Post code28224
    B.5.3.4CountrySpain
    B.5.4Telephone number++34913517978
    B.5.5Fax number++34913518799
    B.5.6E-mailacallejo@non-casenfleet.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 Yes
    D.2.1.1.1Trade name CitraFleet, Powder for oral solution in sachet / CitraFleet Pulver zur Herstellung einer Lösung zum Einnehmen in einem Beutel
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Casen-Fleet S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder for oral solution in sachet
    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 INNSODIUM PICOSULFATE
    D.3.9.1CAS number 10040-45-6
    D.3.9.4EV Substance CodeSUB10569MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAGNESIUM OXIDE, LIGHT
    D.3.9.1CAS number 1309-48-4
    D.3.9.4EV Substance CodeSUB12130MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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.3.9.4EV Substance CodeSUB29050
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.97
    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
    Cleansing of colon
    Reinigung des Darmes
    E.1.1.1Medical condition in easily understood language
    Cleansing of colon before a colonoscopy
    Reinigung des Darmes vor einer Darmspiegelung
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10010007
    E.1.2Term Colonoscopy
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical effectiveness as defined by adequate bowel cleansing (excellent + good) versus inadequate bowel cleansing (fair + poor) of a split-dose administration schedule of CitraFleet (PM/AM) to the product’s currently approved SmPC regimen.
    Vergleich eines Verabreichungsplans mit Teildosierung von CitraFleet (ABENDS/MORGENS) mit dem derzeit zugelassenen SmPC-Medikamentenregime des Produkts hinsichtlich der klinischen Wirksamkeit gemäß Definition als ausreichende Darmreinigung (ausgezeichnet und gut) gegenüber einer nicht ausreichenden Darmreinigung (mittelmäßig und schlecht).
    E.2.2Secondary objectives of the trial
    - Secondary effectiveness objectives of the study are to compare the:
    • Percentage of colonoscopies graded as excellent, good, fair and poor for each of the regimens
    • Number of adequate and inadequate bowel preparations
    • Percentage of colonoscopies graded as poor
    • Segmental residual stool assessments
    • Colonoscopy completion rates
    • Polyp detection rates
    - acceptability
    - tolerability
    - safety with regard to
    • Selected laboratory parameters
    • Vital signs
    • Adverse events (AEs)
    - Die sekundären Zielsetzungen dieser Studie hinsichtlich Wirksamkeit bestehen im Vergleich von:
    • Anteil der Koloskopien mit Einstufung der einzelnen Medikamentenregimes als ausgezeichnet, gut, mittelmäßig und schlecht
    • Anzahl der ausreichenden und nicht ausreichenden Darmvorbereitungen je Medikamentenregime nach Geschlecht und Altersgruppe
    • Anteil der Koloskopien mit Einstufung als schlecht je Medikamentenregime
    • Segmentale Bewertung von Reststuhl je Medikamentenregime
    • Koloskopie-Abschlussraten je Medikamentenregime
    • Polypenerkennungsraten je Medikamentenregime
    - Akzeptanz
    - Verträglichkeit
    - Sicherheit in Bezug auf
    • ausgewählten Laborwerten
    • Vitalzeichen
    • unerwünschten Ereignissen (UEs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 18 years and older
    2. men or non-pregnant women.
    3. Subjects undergoing elective colonoscopy
    4. Subjects who, in the opinion of the Investigator, are able and willing to follow their assigned low-residue diet and hydration regimen
    5. Subjects who, in the opinion of the Investigator, are able and willing to comply with study requirements, with special emphasis on dosing instructions and diary completion.
    6. Subjects who have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    7. Subjects who have hand-signed and dated their informed consent form
    1. Alter: 18 Jahre oder älter
    2. Männer oder nicht schwangere Frauen.
    3. Teilnehmer, die sich einer elektiven Koloskopie unterziehen
    4. Teilnehmer, die nach Ansicht des Prüfarztes in der Lage und bereit sind, die ihnen zugewiesene rückstandsarme Diät und das Hydratationsregime zu befolgen
    5. Teilnehmer, die nach Ansicht des Prüfarztes in der Lage und bereit sind, die Studienanforderungen zu befolgen, mit besonderem Schwerpunkt auf Dosierungsanweisungen und Tagebuchführung.
    6. Teilnehmer, die nicht auf gerichtliche oder behördliche Anordnung hin in einer Anstalt untergebracht sind
    7. Teilnehmer, die die Einwilligungserklärung eigenhändig unterschrieben und datiert haben.
    E.4Principal exclusion criteria
    1. Congestive heart failure or decompensated heart insufficiency
    2. Gastrointestinal conditions contraindicating the administration of CitraFleet: nausea and vomiting, gastric retention, gastro-intestinal ulceration, ileus, toxic colitis, toxic megacolon, gastro-intestinal obstruction or perforation, active inflammatory bowel disease
    3. Ascites
    4. Acute surgical abdominal conditions such as acute appendicitis
    5. Severe dehydration
    6. Hypermagnesaemia
    7. Rhabdomyolysis
    8. Hypersensitivity to any of the ingredients of the IP
    9. Ingestion of an investigational product within 1 month prior to screening
    10. Severe chronic kidney disease (ie, stage >3 chronic kidney disease [CKD])
    11. Have, in the opinion of the investigator, any condition that may make them unsuitable for inclusion in the study
    1. Kongestive Herzinsuffizienz oder dekompensierte Herzinsuffizienz
    2. Gastrointestinale Erkrankungen, die Gegenanzeigen für die Gabe von CitraFleet sind: Übelkeit und Erbrechen, gastrische Retention, gastrointestinale Ulzeration, Darmverschluss, toxische Colitis, toxischer Megacolon, gastrointestinale Obstruktion oder Perforation, aktive entzündliche Darmerkrankung
    3. Aszites
    4. Akute chirurgische Abdominal-erkrankungen wie akute Appendizitis
    5. Schwere Dehydrierung
    6. Hypermagnesiämie
    7. Rhabdomyolyse
    8. Hypersensibilität gegenüber einem der Inhaltsstoffe des Prüfpräparats
    9. Einnahme eines Prüfpräparats innerhalb 1 Monats vor dem Screening
    10. Schwere chronische Nierenerkrankung (d. h. chronische Nierenerkrankung der Stufe > 3 [CKD])
    11. Vorliegen eines Zustands, der die Teilnehmer nach Ansicht des Prüfarztes für den Einschluss in die Studie ungeeignet machen könnte
    E.5 End points
    E.5.1Primary end point(s)
    A superiority analysis will be performed on the ITT population. Preparations rated “excellent” and “good” will be combined to indicate an adequate bowel cleansing (clinically effective), and ratings of “fair” and “poor” will be combined to indicate an inadequate bowel preparation (clinically ineffective).
    A superiority model using logistical regression with factors of regimen, site, gender and age group in the model to account for any variation these factors may have on clinical effectiveness. Statistical significance between regimens will be demonstrated at a significance level of 0.05 or smaller.
    An der ITT-Population wird eine Überlegen-heitsanalyse durchgeführt. Vorbereitungen mit der Bewertung „ausgezeichnet“ und „gut“ werden kombiniert und bezeichnen eine ausreichende Darmreinigung (klinisch wirksam), und die Bewertungen „mittelmäßig“ und „schlecht“ werden kombiniert und bezeichnen eine nicht ausreichende Darmreinigung (klinisch unwirksam).
    Ein Überlegenheitsmodell mithilfe logistischer Regression mit den Faktoren Medikamentenregime, Prüfzentrum, Geschlecht und Altersgruppe, um Abweichungen, die diese Faktoren auf die klinische Wirksamkeit haben können, zu berücksichtigen. Statistische Signifikanz zwischen den Medikamentenregimes wird bei einem Signifikanzniveau von 0,05 oder darunter gezeigt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 and Visit 4
    Besuch 3 and 4
    E.5.2Secondary end point(s)
    - ITT population: analysis of secondary effectiveness endpoints. Comparison of endpoints between regimens will be performed with 95% confidence intervals or P-values
    - ITT population: analysis of acceptability and tolerability endpoints.
    - Safety population: analysis of secondary safety endpoints
    - ITT Population: Analyse der sekundären Wirksamkeitsendpunkte. Ein Vergleich der Endpunkte zwischen den Medikamenten-regimes wird mit einem 95%igen Konfidenzintervall oder P-Werten
    - ITT Population: Analyse der Endpunkte Akzeptanz und Verträglichkeit
    - Sicherheitspopulation: Analyse der sekundären Sicherheitsendpunkte
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 4
    Besuch 4
    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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dasselbe Produkt, aber unterschiedliches Verabreichungsschema
    same product however, different administration schedule
    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 concerned5
    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;
    In case any unresolved laboratory values and/or AEs are CTCAE grade ≥3 at Visit 4, the subject will be asked to return for additional safety follow-up assessments
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state320
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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)
    All subjects who end their participation in the trial will continue to be monitored by their respective physicians, using standard medical care. No special procedures or extra medical care is needed after the trial that would not be otherwise used in patients who have not participated in the trial because the investigational medicinal product is specifically for diagnosis preparation.


    Alle Patienten werden nach Studienende von ihren zuständigen Ärzten betreut. Keine speziellen Vorkehrungen oder besondere medizinische Betreuung ist nach Studienende notwendig, die nicht auch Patienten erhalten würden, wenn sie nicht in er Studie teilgenommen hätten, da das Prüfmuster speziell für die Diagnosevorbereitung verwendet wird.
    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 Decision2013-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-31
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