Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35654   clinical trials with a EudraCT protocol, of which   5853   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001790-33
    Sponsor's Protocol Code Number:AGO/2016/005
    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:2016-05-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-001790-33
    A.3Full title of the trial
    A PHASE II, SINGLE-CENTRE, PROSPECTIVE EXPLORATORY TRIAL TO ASSESS THE EFFICACY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF ACUTE RADIATION INDUCED DIARRHEA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE II, SINGLE-CENTRE, PROSPECTIVE EXPLORATORY TRIAL TO ASSESS THE EFFICACY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF ACUTE RADIATION INDUCED DIARRHEA
    A.4.1Sponsor's protocol code numberAGO/2016/005
    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 SponsorUniversity Hospital Ghent
    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 supportIpsen
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Ghent
    B.5.2Functional name of contact pointDe Crop Maaike
    B.5.3 Address:
    B.5.3.1Street AddressDe Pintelaan 185
    B.5.3.2Town/ cityGent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3293320504
    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 Somatuline Autogel Injectable 60 / 90 / 120 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN nv
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    radiation induced diarrhoea
    E.1.1.1Medical condition in easily understood language
    radiation induced diarrhoea
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To assess the response (complete and/or partial) of lanreotide autogel 120 mg as add-on to loperamide 16 mg on stool frequency and loperamide intake in patients with radiation induced diarrhea not enough responding to loperamide 16 mg monotherapy compared to baseline.
    E.2.2Secondary objectives of the trial
    1. To assess the effect of the add-on of lanreotide autogel 120 mg on Quality of Life (QOL) at day 14, 28, 42 and 3 months compared to baseline.
    2. To assess the timing of the first and maximal effect of lanreotide autogel 120 mg on radiation induced diarrhea.
    3. To assess the effect of lanreotide autogel 120 mg on the duration of radiation induced diarrhea after ending therapy.
    4. To assess any difference in response or effect on QOL of lanreotide autogel 120mg if concomitant chemotherapy is used.
    5. To investigate the safety and tolerability of lanreotide autogel 120 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patient with radiation induced diarrhoea requiring daily loperamide intake (≥16mg) for at least 3 consecutive days.
    • Administration of lanreotide 120mg at least 7 days before ending radiotherapy.
    • ≤ 3 stools per 24 hours before radiotherapy
    • > 3 stools per 24 hours in the screening period.
    • Subject having provided written informed consent prior to any study related procedures
    • Subject of 18 years and older
    • Subject mentally fit for completing a diary
    E.4Principal exclusion criteria
    • Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea,
    • Has received a treatment with somatostatin analogues for any other indication within the last 6 months before study entry,
    • Has received a treatment with laxatives within the last week before study entry,
    • Suffers from IBS with alternating bowel habits and predominant constipation,
    • Suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn´s disease and macroscopic colitis),
    • Has a known intolerance to lanreotide or other somatostatin analogues,
    • Has abnormal baseline findings or any other medical condition(s) that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Complete response: loperamide-intake reduction of 75% or more and ≤ 3 stools per 24 hours.
    Partial response: loperamide-intake reduction of 50% up to 75% and ≤ 3 stools per 24 hours
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response is assessed at day 14 (d12-14), 28 (d26-28) and 42 (d40-42) compared to baseline (d-3 to d-1).
    E.5.2Secondary end point(s)
    • Change in QOL (assess using EQ-5D-5L, EORTC QLQ-C30) at Day 14/28 compared to baseline
    • Timing of first partial and complete response
    • Timing of normalization of stools (no loperamide intake and <3/stools per 24 hours) after ending of treatment if no complete response was reached during treatment
    • Assessing any difference in primary or secondary (point 1 to 3) effect between patients receiving concomitant chemotherapy or not receiving chemotherapy.
    • Incidence of all adverse events will be recorded
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in QOL (assess using EQ-5D-5L, EORTC QLQ-C30) at Day 14/28 compared to baseline
    • Timing of first partial and complete response
    • Timing of normalization of stools (no loperamide intake and <3/stools per 24 hours) after ending of treatment if no complete response was reached during treatment
    • Assessing any difference in primary or secondary (point 1 to 3) effect between patients receiving concomitant chemotherapy or not receiving chemotherapy throughout the trial.
    • Incidence of all adverse events will be recorded throughout the trial
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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
    The study will be considered to have finished after the last patient has completed the last visit of the open label phase.
    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 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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    normal treatment of that condition - loperamide intake
    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 Decision2016-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-27
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA