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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-003784-23
    Sponsor's Protocol Code Number:ML3244
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-31
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-003784-23
    A.3Full title of the trial
    EEN FASE II STUDIE DIE DE WERKZAAMHEID NAGAAT VAN SANDOSTATINE LAR® 20 MG EN 30 MG IN DE PREVENTIE VAN CHEMOTHERAPIE EN RADIOTHERAPIE GEÏNDUCEERDE DIARREE BIJ PATIËNTEN DIE PREOPERATIEF BEHANDELD WORDEN VOOR EEN RECTUMTUMOR.
    A.4.1Sponsor's protocol code numberML3244
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital Gasthuisberg
    B.1.3.4CountryBelgium
    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 organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameSandostatine long acting repeatable (LAR)
    D.3.2Product code Octreotide LAR
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOctreotide Long Acting Repeatable (LAR)
    D.3.9.1CAS number 83150-76-9
    D.3.9.2Current sponsor codeML-3244
    D.3.9.3Other descriptive nameoctreotide acetate LAR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 nameSandostatine long acting repeatable (LAR)
    D.3.2Product code Octreotide LAR
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOctreotide Long Acting Repeatable (LAR)
    D.3.9.1CAS number 83150-76-9
    D.3.9.2Current sponsor codeML-3244
    D.3.9.3Other descriptive nameoctreotide acetate LAR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Locally advanced rectal cancer patients receiving preoperative chemoradiotherapy
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    De werkzaamheid nagaan van een éénmalige injectie Sandostatine® LAR IM van 20 mg of 30 mg in de preventie van de toename van diarree met minstens één graad ten gevolge van radiochemotherapie (CTCAE v3.0) bij patiënten die preoperatief bestraald worden voor een lokaal geavanceerd rectumcarcinoom en reeds voor de start van de bestraling last hebben van diarree (toename van 2-6 stoelgangen tov. vroeger of overloopdiarree). Diarree zal beoordeeld worden aan de hand van de CTCAE v3.0 in de 2 testgroepen.
    E.2.2Secondary objectives of the trial
    • In een tweede stap zullen we nagaan of er een verschil in werkzaamheid is tussen 20 mg en 30 mg Sandostatine® LAR.
    • De levenskwaliteit van de patiënt scoren in de 2 groepen aan de hand van 3 scoresystemen. (QOL-RTI, EPIC en FACE).
    • De nood aan bijkomende anti-diarree behandeling beoordelen.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Histologisch bewezen lokaal uitgebreid (T3/T4 en/of N+) adenocarcinoma van het rectum zonder metastasen op afstand.
    - Patiënten met een graad 1 of 2 diarree ten gevolge van de rectumtumor of met overloopdiarree ten gevolge van een (sub)obstruerende rectumtumor (toename van 2-6 stoelgangen per dag tov. vroeger)
    - Gepland beleid is een lang schema concomitante preoperatieve radio-chemotherapie (zie sectie 5).
    - Patiënt is ouder dan 18 jaar.
    - Patiënt moet een ‘informed consent’ tekenen alvorens hij/zij kan aan het onderzoek kan deelnemen.
    E.4Principal exclusion criteria
    - Patiënten die vroeger reeds op de pelvis bestraald werden of een bestraling kregen voor een abdominale tumor.
    - Patiënten met een gekende allergie/hypersensitiviteit voor Sandostantine® of aanverwante medicatie.
    - Patiënten die vroeger reeds behandeld werden met Sandostantine® voor tumor-gerelateerde diarree.
    - Patiënten met een voorgeschiedenis van enteritis, malabsorptie syndroom of inflammatoire darmpathologie.
    - Patiënten met ongecontroleerde diabetes.
    - Patiënten die gekend zijn met cholecystitis of galstenen (tenzij een cholecystectomie werd uitgevoerd).
    - Patiënten die gekend zijn met leverpathologie (tenzij de LFT’s < 3 x de bovengrens van de normaalwaarde zijn).
    - Patiënten met niet te controleren diarree (≥ G2) of incontinentie voor stoelgang vóór de start van de bestraling, niet ten gevolge van de rectumtumor en niet ten gevolge van overloopdiarree veroorzaakt door een (sub)obstruerende rectumtumor.
    - Patiënten met een colostomie of patiënten die een APR (abdomino-perineale resectie) of andere chirurgie ondergingen waardoor het rectum afunctioneel is.
    - Patiënten die binnen de 6 maanden voor inclusie behandeld zijn met glucocorticoiden, insuline sensitizers, of exogeen groeihormoon.
    - Patiënten die andere studiemedicatie kregen binnen de 30 dagen voor inclusie.
    - Zwangere vrouwen of vrouwen die borstvoeding geven zijn geen kandidaat, gezien de medicatie onvoorspelbare schade kan toebrengen aan de vrouw of het ongeboren kind.
    - HIV positieve patiënten, gezien groter risico op niet te controleren diarree.
    E.5 End points
    E.5.1Primary end point(s)
    • De werkzaamheid nagaan van een éénmalige injectie Sandostatine® LAR IM van 20 mg of 30 mg in de preventie van de toename van diarree met minstens één graad ten gevolge van radiochemotherapie (CTCAE v3.0) bij patiënten die preoperatief bestraald worden voor een lokaal geavanceerd rectumcarcinoom en reeds voor de start van de bestraling last hebben van diarree (toename van 2-6 stoelgangen tov. vroeger of overloopdiarree). Diarree zal beoordeeld worden aan de hand van de CTCAE v3.0 in de 2 testgroepen.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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 Decision2005-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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