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    Summary
    EudraCT Number:2017-002143-15
    Sponsor's Protocol Code Number:RLM-MD-03
    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:2018-08-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002143-15
    A.3Full title of the trial
    A 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    Étude de phase 3 d’une durée de 46 semaines, en double aveugle, avec une période de retrait randomisée de 6 semaines contrôlée par placebo évaluant la sécurité d'emploi et l'efficacité de la relamoreline chez des patients atteints de gastroparésie diabétique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 46-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    Étude d’une durée de 46 semaines évaluant la sécurité d'emploi et l'efficacité de la relamoreline chez des patients atteints de gastroparésie diabétique.
    A.3.2Name or abbreviated title of the trial where available
    Diabetic Gastroparesis Study with Randomized-withdrawal Period
    Étude de la gastroparésie diabétique avec une période d'arrêt randomisée
    A.4.1Sponsor's protocol code numberRLM-MD-03
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointNick Connolly
    B.5.3 Address:
    B.5.3.1Street AddressMarlow, International, Parkway
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)1628 494387
    B.5.5Fax number+44(0)1628 494887
    B.5.6E-mailConnolly_Nick@allergan.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 nameRelamorelin
    D.3.2Product code RM-131
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNRELAMORELIN
    D.3.9.1CAS number 661472-41-9
    D.3.9.2Current sponsor codeRM-131
    D.3.9.3Other descriptive nameInp-DBal-DTrp-Phe-Apc-NH2
    D.3.9.4EV Substance CodeSUB182309
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 Yes
    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 in pre-filled pen
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Gastroparesis
    Gastroparésie diabétique
    E.1.1.1Medical condition in easily understood language
    Diabetic Gastroparesis
    Gastroparésie diabétique
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10051153
    E.1.2Term Diabetic gastroparesis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study (ie, after a total of 24 weeks of treatment—12 weeks from lead-in study RLM-MD-01 or from lead-in study RLM-MD-02 and 12 weeks from the current study) in participants with DG with respect to the following core signs and symptoms of DG: nausea, abdominal pain, postprandial fullness, bloating.

    To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in this study (ie, after a total of 24 weeks of treatment—12 weeks from lead-in study RLM-MD-01 or from lead-in study RLM-MD-02 and 12 weeks from the current study) in participants with DG with respect to vomiting frequency
    Comparer l'efficacité de la rélamoréline à celle du placebo après 12 semaines de traitement dans cette étude (c.-à-d. après un total de 24 semaines de traitement avec 12 semaines dans l'étude préparatoire RLM-MD-01 ou dans l'étude préparatoire RLM-MD-02 et 12 semaines dans la présente étude) chez les participants atteints de GD en ce qui concerne les principaux signes et symptômes de GD suivants : Nausées, Douleurs abdominales, Satiété postprandiale, Ballonnements.

    Comparer l'efficacité de la rélamoréline à celle du placebo après 12 semaines de traitement dans cette étude (c.-à-d. après un total de 24 semaines de traitement avec 12 semaines dans l'étude préparatoire RLM-MD-01 ou dans l'étude préparatoire RLM-MD-02 et 12 semaines dans la présente étude) chez les participants atteints de GD en ce qui concerne la fréquence des vomissements.
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of relamorelin with placebo after 12 weeks of treatment in this study in participants with DG with respect to the following individual symptoms of the DGSSS: nausea, abdominal pain, postprandial fullness, bloating
    - To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study in participants with DG with respect to the following core signs and symptoms of DG: nausea, abdominal pain, postprandial fullness, bloating
    - To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study in participants with DG with respect to vomiting frequency
    - At the end of the 6-week randomized-withdrawal period (RWP), to demonstrate maintenance of efficacy among participants who were switched from relamorelin to placebo vs participants who continued relamorelin treatment
    To compare the safety of relamorelin with placebo in participants with DG
    - Comparer l’efficacité de la rélamoréline à celle du placebo apres 12 semaines de traitement dans cette étude chez les participants atteints de GD en ce qui concerne les symptômes individuels du DGSSS suivants : Nausées, Douleurs abdominales, Satiété postprandiale, Ballonnements
    - Comparer l'efficacité de la rélamoréline à celle du placebo après 40 semaines de traitement dans cette étude chez les participants atteints de GD en ce qui concerne les principaux signes et symptômes de GD suivants : Nausées, Douleurs abdominales, Satiété postprandiale ,Ballonnements
    - Comparer l'efficacité de la rélamoréline à celle du placebo après 40 semaines de traitement dans cette étude chez les participants atteints de GD en ce qui concerne la fréquence des vomissements
    - Démontrer le maintien de l'efficacité de traitement pendant la période d'arrêt randomisée (PAR) de 6 semaines
    - Comparer la sécurité d'emploi de la rélamoréline à celle du placebo chez les participants atteints de GD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant met all inclusion/exclusion criteria of either Protocol RLM-MD-01 or Protocol RLM-MD-02 and successfully completed the study
    2. Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
    3. In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02

    1. Participant répondant à toutes les critères d'inclusion et de non inclusion du protocole de l'étude RLM-MD-01 ou du protocole de l'étude RLM-MD-02 et ayant terminé avec succès l'étude
    2. Être capable de fournir un consentement éclairé (CE) écrit avant de débuter toute procédure de l'étude et être prêt(e) à et capable de se conformer aux procédures de l'étude
    3. Selon l'investigateur, le participant a montré une adhérence adéquate aux procédures de l'étude dans l'étude RLM-MD-01 ou RLM-MD-02
    E.4Principal exclusion criteria
    1. Participant is not willing or able to abide by the restrictions regarding concomitant medicine use
    2. Participant is planning to receive an investigational drug (other than study treatment) or investigational device at any time during Study RLM-MD-03
    3. Participant has an unresolved AE or a clinically significant finding on physical examination, clinical laboratory test, or 12-lead ECG that, in the investigator’s opinion, would limit the participant’s ability to participate in or complete the study
    4. Any other reason that, in the investigator’s opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic or cardiopulmonary disease
    5. Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, other study staff member, or employee of Allergan, Inc.; or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site
    1. Le participant n'est pas disposé ou capable de respecter les restrictions concernant l'utilisation de médicaments concomitants
    2. Le participant prévoit de recevoir un médicament expérimental (autre que le traitement à l'étude) ou un dispositif expérimental à tout moment au cours de l'étude RLM-MD-03
    3. Le participant a développé un EI non résolu ou présente un résultat significatif sur le plan clinique lors de l'examen clinique, aux analyses cliniques de laboratoire ou à l'ECG à 12 dérivations qui, selon l'investigateur, pourrait limiter sa capacité à participer à ou à terminer l'étude
    4. Toute autre raison qui, selon l'investigateur, pourrait fausser l'interprétation de l'étude ou exposer un participant à un risque inacceptable, y compris à une maladie rénale, hépatique ou cardiopulmonaire
    5. Le participant est directement ou indirectement impliqué dans la réalisation et l'administration de cette étude en tant qu'investigateur, co-investigateur, coordinateur de l'étude, un autre membre du personnel de l'étude, ou un employé d'Allergan, Inc. ; ou le participant est un membre de la famille au premier degré, une autre personne importante ou un proche habitant avec l'une des personnes mentionnées ci-dessus impliquée directement ou indirectement dans l'étude ; ou le participant est inclus dans cette étude dans un autre centre d'étude clinique
    E.5 End points
    E.5.1Primary end point(s)
    • The Diabetic Gastroparesis Symptom Severity Score (DGSSS) Week-12 Responder
    • Vomiting Week-12 Responder
    • Répondeurs concernant le score de sévérité des symptômes de gastroparésie diabétique (DGSSS) à la semaine 12
    • Répondeurs concernant les vomissements à la semaine 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Semaine 12
    E.5.2Secondary end point(s)
    • Individual Symptom (ie, nausea, abdominal pain, postprandial fullness, and bloating) Week-12 Responder
    • DGSSS Week-40 Responder
    • Change from Baseline (CFB) to Week 40 in the average weekly DGSSS
    • Vomiting Frequency at Week 40
    • CFB to Week 40 in the average weekly number of vomiting episodes
    • CFB to end of RWP in the average weekly DGSSS
    • CFB to end of RWP in the number of vomiting episodes
    • AEs, clinical laboratory values, vital signs, electrocardiograms (ECGs), HbA1c, and anti-relamorelin antibodies
    • Répondeurs concernant les symptômes individuels (c.-à-d. nausées, douleurs abdominales, satiété postprandiale et ballonnements) à la semaine 12
    • Répondeurs concernant le DGSSS à la semaine 40
    • Variation entre l’inclusion et la semaine 40 du DGSSS hebdomadaire moyen
    • Fréquence des vomissements à la semaine 40
    • Variation entre l’inclusion et la semaine 40 du nombre hebdomadaire moyen d’épisodes de vomissements
    • Variation entre l’inclusion et la fin de la PAR du DGSSS hebdomadaire moyen
    • Variation entre l’inclusion et la fin de la PAR du nombre d’épisodes de vomissements
    • Les EI, les paramètres cliniques aux analyses de laboratoire clinique, les signes vitaux, les électrocardiogrammes (ECG), le taux d’HbA1c et le taux d’anticorps anti-rélamoréline
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 40
    Semaine 40
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA174
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Colombia
    Denmark
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Latvia
    Malaysia
    Mexico
    Philippines
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Spain
    Taiwan
    Thailand
    Ukraine
    United Arab Emirates
    United Kingdom
    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 end of the study is defined as the date of the last visit of the last participant in the study.
    La fin de l'étude est définie comme la date de la dernière visite du dernier participant à l'étude.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days10
    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: 720
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 328
    F.4.2.2In the whole clinical trial 960
    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)
    Participants who complete the study should follow up with the investigator regarding treatment at the end of the study
    Les participants terminant l'étude devraient faire un suivi auprès de l'investigateur concernant le traitement à la fin de l'étude
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Network, UK
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-29
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