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    Summary
    EudraCT Number:2017-002144-33
    Sponsor's Protocol Code Number:RLM-MD-04
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-31
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-002144-33
    A.3Full title of the trial
    A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    52 hetes, randomizált, kettős vak, placebo-kontrollos, III. fázisú vizsgálat a relamorelin biztonságosságának és hatásosságának értékelésére diabéteszes gasztroparézisben szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    52 hetes vizsgálat, a relamorelin biztonságosságának és hatásosságának értékelésére diabéteszes
    gasztroparézisben szenvedő betegeknél
    A.3.2Name or abbreviated title of the trial where available
    Diabetic Gastroparesis Study 4
    A.4.1Sponsor's protocol code numberRLM-MD-04
    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 pointAllergan Ltd EU Regulatory Dept.
    B.5.3 Address:
    B.5.3.1Street AddressMarlow, International, Parkway
    B.5.3.2Town/ cityMarlow/ Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)1628 494444
    B.5.5Fax number+44(0)1628 494449
    B.5.6E-mailml-ct@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
    E.1.1.1Medical condition in easily understood language
    Diabetic Gastroparesis
    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 in participants with DG with respect to composite of the following core signs and symptoms of DG
    o Nausea
    o Abdominal pain
    o Postprandial fullness
    o Bloating
    • To compare the safety of relamorelin with that of placebo in participants with DG
    E.2.2Secondary objectives of the trial
    To assess relamorelin treatment effect on individual symptoms of DG such as nausea, abdominal pain, bloating, postprandial fullness, and vomiting
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Rollover Participants:
    Participants who were not randomization-eligible at the end of the Run-in Period of lead-in Studies RLM-MD-01 or RLM-MD-02 are eligible to be randomized in the study if all of the following criteria apply:
    In the lead-in studies, participants must have met all Screening Visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the DGSSD) except that:
    1. They had zero vomiting episodes and an average daily DGSSS of ≥ 12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device;
    OR
    2. They had vomiting episodes and an average daily DGSSS of ≥ 12 but < 16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device.

    De Novo Participants
    Participants who undergo screening and run-in procedures for Study RLM MD-04 are eligible to be included in the study if all of the following criteria apply:
    1. Male or female participants aged 18 years or older at Screening (Visit –2)
    2. T1DM or T2DM of at least 5 years’ duration, with controlled and stable blood glucose levels (ie, no episodes of diabetic ketoacidosis, Hyperosmolar Hyperglycemic Nonketotic Diabetic Syndrome, or severe hypoglycemia within the 6 months preceding Screening [Visit –2])
    3. HbA1c ≤ 11.0% at Screening (Visit –2) in participants being treated with oral and/or parenteral medications for T1DM or T2DM with the goal of achieving controlled and stable glucose levels
    4. DG defined as at least a 3-month history prior to Screening (Visit –2) of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of GP (eg, nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
    5. Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and Follow-up Period
    A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization, not breastfeeding, and at least one of the following conditions applies:
    a. Not a woman of childbearing potential (WOCBP)
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 7 days after the last dose of study treatment
    6. Documentation of absence of an obstructing lesion on upper GI series with contrast or upper endoscopy, performed at some time before Run-in period (Visit –2) but after the appearance of symptoms that led to the diagnosis of DG
    7. Nausea and/or at most a single episode of vomiting during the 2 weeks prior to Screening (Visit –2), as ascertained by participant history
    8. Delayed GE confirmed by abnormal GEBT, defined as GE half-time (t½) ≥ 79 minutes at the start of the placebo-controlled Run-in Period (Visit 2 of RLM-MD-01, RLM-MD-02, or this study). In countries where the GEBT is not available, delayed GE may be confirmed by abnormal scintigraphy result (> 60% retention at 2 hours or > 10% at 4 hours)
    9. The BMI criterion has been removed.
    10. Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
    Additional inclusion criteria for randomization after the 2-week, placebo Run-in Period:
    11. Compliance with the entry of data into the hand-held electronic device on at least 10 of 14 days during the Run-in Period
    12. Compliance with administration of SC twice daily injections, as evidenced by entries made by the participant using the electronic, hand-held device on at least 10 of 14 days during the Run-in Period
    13. The average of the daily DGSSS from the 2-week, Run-in Period must be ≥ 12
    E.4Principal exclusion criteria
    Both Rollover and De Novo Participants
    1. Corrected QT Interval (QTc) > 470 msec in the absence of right or left bundle branch block, other intraventricular conduction delay (IVCD) with QRS duration > 120 msec, or paced beat on the ECG obtained at Screening (Visit 1)
    2. Participants with a known allergy or hypersensitivity to the study treatments and their excipients (ie, mannitol or phenol)
    Rollover Participants
    Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at Screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of Studies RLM MD 01 and RLM MD-02, except as specified in the inclusion criteria
    De Novo Participants
    1. Symptomatic Irritable Bowel Syndrome at Screening (Visit –2)
    2. Small intestinal bacterial overgrowth (SIBO) at Screening (Visit –2)
    3. History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of Screening (Visit –2)
    4. History of intestinal malabsorption (including celiac disease even if well-controlled on a gluten-free diet) or pancreatic exocrine insufficiency; also, history of non-celiac gluten sensitivity
    5. History of belching disorders, other nausea and vomiting disorders (eg, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, cannabinoid hyperemesis syndrome), or rumination syndrome
    6. History of chronic obstructive pulmonary disease or other causes of pulmonary dysfunction that have resulted in CO2 retention
    7. Gastric or duodenal ulcer within 3 months of Screening (Visit 1)
    8. Evidence of hepatic disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, and/or direct bilirubin ≥ 2 x ULN at Screening (Visit 2)
    9. History of malignancy in the 3 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
    10. Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
    11. Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI pro-motility agents for at least 10 days prior to the start of the Run-in Period (Visit –1)
    12. Positive results on the urine drug screen at Screening (Visit -2). The sponsor may permit a participant with a positive urine drug screen (UDS) by immunoassay at Screening to continue in screening while confirmatory testing by a more specific method is carried out on an aliquot of the original urine sample. If the confirmatory test is negative,
    the initial positive UDS will be considered to have been a false-positive urine drug screen and the participant can continue in screening. Confirmatory testing will be done at the discretion of the sponsor and must be approved by the sponsor prior to analysis.
    13. Currently taking opiates, or expecting to use opiates during the course of the clinical study.
    14. Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period (Visit –1)
    15. History of pyloric injection of botulinum toxin within 6 months of screening
    16. History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
    17. Randomization in any previous study in which relamorelin was a treatment
    18. Estimated glomerular filtration rate (eGFR) of < 30 mL/min
    19. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
    20. Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the GEBT study meal
    21. Females who are pregnant, nursing, or planning a pregnancy during the study
    22. The participant has a condition or is in a situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study
    23. 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
    24. Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
    25. Hypersensitivity to the study treatments and their excipients (ie, mannitol or phenol)
    26. Corrected QC Interval (QTc) > 470 msec in the absence of right or left bundle branch block, other intraventricular conduction delay (IVCD) with QRS duration > 120 msec, or paced beat on the ECG obtained at Screening (Visit 1)
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline to Week 12 in the weekly DGSSS
    • Change from baseline to Week 52 in weekly average DGSSS
    • AEs, clinical laboratory values, vital signs, ECGs, HbA1c, and antirelamorelin
    antibodies
    E.5.1.1Timepoint(s) of evaluation of this end point
    - week 12
    - week 52
    E.5.2Secondary end point(s)
    • Change from baseline to Week 12 and Week 52 in the following:
    o Nausea
    o Abdominal pain
    o Bloating
    o Postprandial fullness
    o Vomiting frequency
    E.5.2.1Timepoint(s) of evaluation of this end point
    The whole study duration
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA231
    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
    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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 328
    F.4.2.2In the whole clinical trial 600
    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.
    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 Decision2018-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-05
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