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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2014-004707-67
    Sponsor's Protocol Code Number:2014-880
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-004707-67
    A.3Full title of the trial
    REDUCTION BY PASIREOTIDE OF THE EFFLUENT VOLUME IN HIGH-OUTPUT ENTEROSTOMY IN PATIENTS REFRACTORY TO USUAL MEDICAL TREATMENT: PHASE II MULTICENTRIC RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reduction by pasireotide of the effluent volume in high-output enterostomy in patients refractory to usual medical treatment.
    A.3.2Name or abbreviated title of the trial where available
    SOMILEO
    A.4.1Sponsor's protocol code number2014-880
    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 SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    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 supportNOVARTIS PHARMA
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportHospices Civils de Lyon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointClinical trial Information
    B.5.3 Address:
    B.5.3.1Street Address3 quai des Célestins
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number00334 72 40 68 40
    B.5.5Fax number0033 4 72 11 51 90
    B.5.6E-mailvalerie.plattner@chu-lyon.fr
    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 SIGNIFOR
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPASIREOTIDE DIASPARTATE
    D.3.9.3Other descriptive nameSignifor
    D.3.9.4EV Substance CodeSUB71450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.9
    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 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 namepasireotide long acting release
    D.3.2Product code pasireotide LAR 60mg
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codepasireotide LAR 60mg
    D.3.9.3Other descriptive namePASIREOTIDE PAMOATE
    D.3.9.4EV Substance CodeSUB129748
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with high-output ileostomy or jejunostomy and
    failure of treatment with loperamide +/- codein syrup
    E.1.1.1Medical condition in easily understood language
    Following digestive surgery during which an enterostomy was created , the stomy gives high-output not controlled with usual medical treatment (loperamide +/- codeine).
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10021321
    E.1.2Term Ileostomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10023180
    E.1.2Term Jejunostomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 efficacy of pasireotide versus placebo in reduction of high-output (>1000 ml/24h) enterostomy in patients refractory to usual medical treatment
    E.2.2Secondary objectives of the trial
    - Estimate the success rate of pasireotide and placebo.
    - Compare the decrease in the length of hospitalization with pasireotide versus placebo.
    - Compare the incidence of prematured closure of stoma due to high-output with pasireotide versus placebo.
    - Evaluate the economic impact of pasireotide in this indication.
    - Evaluate the safety of pasireotide in this indication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and Female patients ≥ 18 years old ;
    - Patients with high-output ileostomy or jejunostomy > 1000 ml/24h ;
    - Patients with failure of treatment with loperamide (up to 8 capsules/24h) +/- codein syrup (10 mg x 3/24h) during 5 days ;
    - Patients who gave its written informed consent to participate to the study ;
    - Patients affiliated to a social insurance regime.
    E.4Principal exclusion criteria
    - Male and Female patients < 18 years old ;
    - Patients who did not give its written informed consent to participate to the study ;
    - Patients who received somatostatin analogues during the month before inclusion ;
    - Patients with symptomatic cholelithiasis or acute or chronic pancreatitis ;
    - Patients with uncontrolled diabetes (with HbA1c (glycated hemoglobin) > 8%) ;
    - Patients who are hypothyroid and not on adequate replacement therapy ;
    - Patients who have congestive heart failure (NYHA (New York Heart Association) Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, advanced heart block or a history of clinically significant bradycardia or acute myocardial infarction within the 6 months preceding randomization ;
    - Patients with history of syncope or family history of idiopathic sudden death ;
    - Patients with screening or baseline (predose) : QTcF > 450 msec (male), QTcF > 460 msec (female) (QT interval corrected for heart rate using Fridericia's correction) ;
    - Patients with not corrected hypokalaemia and/or hypomagnesaemia ;
    - Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST (alanine transaminase/aspartate transaminase) > 2 x ULN (Upper Limit of Normal), serum bilirubin > 2 x ULN ;
    - Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control ;
    - Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix) ;
    - Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time) ;
    - Patients with known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR ;
    - Patients under guardianship ;
    - Patients nonaffiliated to a social insurance regime.
    E.5 End points
    E.5.1Primary end point(s)
    The decrease of enterostomy output (ml/24H) evaluated 72 hours after first injection of treatment, in both arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours after first injection of treatment
    E.5.2Secondary end point(s)
    - Number of patients in both arms with an enterostomy output less than 800ml/24h AND a normal renal function (Glomerular Filtration Rate> 90 ml/min according to Cockroft formula) within a week after first injection of treatment, allowing discontinuation of intravenous perfusion.
    - Duration of hospitalization (days), in both arms.
    - Rate of prematured closure of stoma due to high output (before 2 months after creation), in both arms.
    - Costs of taking care of patients from French Public Health Insurance perspective, in both arms (see section 11).
    - Nature, number and grade of adverse events observed throughout the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Number of patients in both arms with an enterostomy output less than 800ml/24h AND a normal renal function within a week after first injection of treatment, allowing discontinuation of intravenous perfusion.

    - Rate of prematured closure of stoma due to high output (before 2 months after creation), in both arms.
    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) 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 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 concerned13
    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 Yes
    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
    Last Patient Last Visit
    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 months20
    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 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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state78
    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)
    usual follow-up by the physician
    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 Decision2016-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-08
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