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    Summary
    EudraCT Number:2016-000723-94
    Sponsor's Protocol Code Number:LP101-CL-201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-000723-94
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Intravenous Ulimorelin (LP101) in Patients with Enteral Feeding Intolerance
    Een fase 2, gerandomiseerd, dubbelblind, comparator-gecontroleerd multicenteronderzoek naar de werkzaamheid, veiligheid en farmacokinetiek van intraveneus ulimoreline (LP101) bij patiënten met intolerantie voor enterale voeding
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Intravenous Ulimorelin (LP101) in Patients with Enteral Feeding Intolerance
    Een fase 2, gerandomiseerd, dubbelblind, comparator-gecontroleerd multicenteronderzoek naar de werkzaamheid, veiligheid en farmacokinetiek van intraveneus ulimoreline (LP101) bij patiënten met intolerantie voor enterale voeding
    A.4.1Sponsor's protocol code numberLP101-CL-201
    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 SponsorLyric Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportLyric Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPivotal, S.L.
    B.5.2Functional name of contact pointJesús González
    B.5.3 Address:
    B.5.3.1Street AddressGobelas 19
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number0034638481992
    B.5.5Fax number003491708 13 01
    B.5.6E-mailjesus.gonzalez@pivotal.es
    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 nameUlimorelin
    D.3.2Product code LP101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUlimorelin
    D.3.9.2Current sponsor codeLP101
    D.3.9.3Other descriptive nameULIMORELIN HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB31967
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 RoleComparator
    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 Metoclopramide
    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 nameMetoclopramide
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETOCLOPRAMIDE
    D.3.9.1CAS number 364-62-5
    D.3.9.2Current sponsor codemetoclopramide
    D.3.9.3Other descriptive namemetoclopramide
    D.3.9.4EV Substance CodeSUB08902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Enteral Feeding Intolerance
    Sondevoeding intolerantie
    E.1.1.1Medical condition in easily understood language
    Enteral Feeding Intolerance
    Sondevoeding intolerantie
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10074293
    E.1.2Term Enteral feeding intolerance
    E.1.2System Organ Class 100000162189
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of multiple daily intravenous (IV) doses of ulimorelin on the proportion of the daily protein prescription (DPP) received through enteral nutrition by mechanically ventilated and tube-fed patients with enteral feeding intolerance (EFI)
    Het beoordelen van het effect van meerdere, dagelijkse, intraveneuze doses ulimoreline op het dagelijkse eiwitvoorschrift (DEV) via enterale voeding bij patiënten met intolerantie voor enterale voeding die mechanisch beademd en via een sonde gevoed worden
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of multiple daily IV doses of ulimorelin on the proportion of the daily caloric prescription (DCP) received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI
    Het beoordelen van het effect van meerdere, dagelijkse, intraveneuze doses ulimoreline op het dagelijkse calorievoorschrift (DCV) via enterale voeding bij patiënten met intolerantie voor enterale voeding die mechanisch beademd en via een sonde gevoed worden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Observation Phase
    •Men and non-pregnant women aged 18 years and above
    •Intubated and mechanically ventilated in the ICU
    •Receiving continuous nasogastric, orogastric, or percutaneous gastric tube feedings
    •A 12-Fr or larger nasogastric, orogastric, or percutaneous gastric feeding tube, with its distal tip at least 10 cm below the gastroesophageal junction and visible in the stomach on a routine radiographic examination within 24 hours of screening
    •At risk for the development EFI, with risk defined as GRV between 300 mL and 499 mL on one or more measurements
    •Expected to remain intubated, mechanically ventilated, and receiving nasogastric orogastric or percutaneous feeding for at least 48 hours
    Efficacy Phase
    •Men and non-pregnant women aged 18 years and above
    •Intubated and mechanically ventilated in the ICU
    •Receiving continuous nasogastric, orogastric, or percutaneous gastric tube feeding, with no contraindication to advancing feedings per the feeding protocol
    •A 12-Fr or larger nasogastric, orogastric, or percutaneous gastric feeding tube, with its distal tip at least 10 cm below the gastroesophageal junction and visible in the stomach on a routine radiographic examination within 24 hours of screening
    •Enteral feeding intolerance, defined as a GRV of ≥ 500 mL on one or more measurements
    •Expected to remain intubated, mechanically ventilated, and receiving nasogastric orogastric or percutaneous feeding for at least 48 hours
    Observatie fase
    1.Mannen en niet-zwangere vrouwen van 18 jaar en ouder
    2. Geïntubeerd en mechanisch beademd op de ICU
    3. Continue voeding via een nasogastrische, orogastrische of percutane maagsonde zonder contra-indicatie voor het opvoeren van de voeding volgens het voedingsprotocol
    4. Een nasogastrische, orogastrische of percutane maagsonde van 12 Fr of meer, waarvan het distale uiteinde zich minstens 10 cm onder de gastro-oesofageale overgang bevindt, en die bij een radiografisch routineonderzoek 24 uur vóór de screening zichtbaar in de maag aanwezig is
    5. Risico op ontwikkeling van EFI, waarbij risico wordt gedefinieerd als een GRV tussen de 300ml en 499ml bij een of meer metingen
    6. naar verwachting geïntubeerd en mechanisch beademd zal blijven en die gedurende ten minste 48 uur nasogastrische orogastrische of percutane voeding krijgt
    Effectiviteits fase:
    1.Mannen en niet-zwangere vrouwen van 18 jaar en ouder
    2. Geïntubeerd en mechanisch beademd op de ICU
    3. Continue voeding via een nasogastrische, orogastrische of percutane maagsonde zonder contra-indicatie voor het opvoeren van de voeding volgens het voedingsprotocol
    4. Een nasogastrische, orogastrische of percutane maagsonde van 12 Fr of meer, waarvan het distale uiteinde zich minstens 10 cm onder de gastro-oesofageale overgang bevindt, en die bij een radiografisch routineonderzoek 24 uur vóór de screening zichtbaar in de maag aanwezig is
    5. Intolerantie voor enterale voeding, gedefinieerd als een GRV van ≥ 500 ml bij een of meer metingen
    6. Patiënt die naar verwachting geïntubeerd en mechanisch beademd zal blijven en die gedurende ten minste 48 uur nasogastrische orogastrische of percutane voeding krijgt
    E.4Principal exclusion criteria
    Observation Phase
    1.Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative. 2.Weight prior to ICU admission exceeding 150.0 kg. 3.Suspicion or confirmation of active bowel obstruction, perforation, or leakage. 4.History of esophageal or gastric surgery prior to or during the current hospital admission. 5.Patient’s clinical condition is deteriorating rapidly, or the Investigator does not consider there to be a reasonable expectation that the patient will complete the study. 6.Childs C cirrhosis (ALT elevations are not excluded in the Observation Phase, as these can resolve on follow-up)
    Efficacy Phase
    1.Inability to obtain written informed consent to participate in the study from the patient or legally authorized representative. (Whenever possible, patients who participate based on proxy consent will be re-consented once deemed capable by the Investigator of providing consent on their own.) 2.Weight prior to ICU admission exceeding 150.0 kg. 3.Suspicion or confirmation of active bowel obstruction, perforation, or leakage. 4.History of esophageal or gastric surgery prior to or during the current hospital admission. 5.Use of any of the following prokinetic medications is allowed until 48 hours before randomisation but prohibited from 48 hours prior to randomisation through the 5 days of treatment with study drug: domperidone, cisapride, neostigmine, or opioid antagonists, including alvimopan, naloxone, naltrexone, or analogs of naloxone or naltrexone; erythromycin or azithromycin. [N.B., azithromycin is permitted for treatment of pulmonary infections up to 48 hours before randomization, but not thereafter through Day 5. Up to 2 doses of metoclopramide are permitted within 48 hours of randomisation, provided that metaclopramide is not administered within 10 hours of the first dose of study drug or at any time through Day 5. If a patient receives metoclopramide during the screening period, a radiologic examination must confirm that the feeding tube remains visible in the stomach after the final dose of drug during screening and prior to the start of baseline gastric emptying measurements and has not migrated to the duodenum. Use of clarithromycin for any indication is not excluded.]. 6.QT interval corrected using Fridericia’s formula (QTcF) > 480 msec on a 12-lead ECG during screening. 7. Patient’s clinical condition is deteriorating rapidly, or the Investigator does not consider there to be a reasonable expectation that the patient will complete the study. 8.Childs C cirrhosis or ALT ≥ 1000 U/L
    Observatiefase
    1.Onvermogen schriftelijke geïnformeerde toestemming voor deelname aan het onderzoek te verkrijgen van de patiënt of een wettelijke vertegenwoordiger. 2.Gewicht meer dan 150,0 kg vóór de ICU opname 3.Vermoeden of bevestiging van actieve darmobstructie, -perforatie of lekkage 4.Voorgeschiedenis van slokdarm- of maagchirurgie vóór of tijdens de huidige ziekenhuisopname 5. De klinische toestand van de patient verslechtert snel, of de onderzoeker is van mening is er een redelijke verwachting dat de patiënt de studie niet zal voltooien. 6. Childs C cirrose (ALT verhogingen worden niet geexcludeerd in de observatie fase omdat deze in de follow-up kunnen oplossen).

    Effectiviteitsfase
    1. Onvermogen om schriftelijke geïnformeerde toestemming voor deelname aan het onderzoek te verkrijgen van de patiënt of een wettelijke vertegenwoordiger. 2. Gewicht van meer dan 150,0 kg vóór de ICU opname. 3. Vermoeden of bevestiging van actieve darmobstructie, -perforatie of lekkage. 4. Voorgeschiedenis van slokdarm- of maagchirurgie vóór of tijdens de huidige ziekenhuisopname. 5. Gebruik van de volgende prokinetische medicatie is toegestaan tot 48 uur voor randomisatie maar verboden vanaf 48 uur voor randomisatie tot aan het einde van de behandeling met study medicatie op dag 5: domperidon, cisapride, neostigmine of opioïdantagonisten, waaronder alvimopan, naloxon, naltrexon of analogen van naloxon of naltrexon; erytromycine of azitromycine [N.B.: azitromycine is toegestaan voor de behandeling van longinfecties tot 48 uur vóór randomisatie, maar daarna tot en met dag 5 niet meer. Van metoclopramide zijn binnen 48 uur van randomisatie, maximaal 2 doses toegestaan op voorwaarde dat metoclopramide niet wordt toegediend binnen 10 uur voorafgaand aan de eerste dosis van het onderzoeksgeneesmiddel of op enig moment tot en met dag 5. Als een patiënt tijdens de screeningperiode metoclopramide krijgt toegediend, moet met een radiologisch onderzoek worden aangetoond dat de voedingssonde nog steeds zichtbaar is in de maag na de laatste dosis van het geneesmiddel tijdens de screening en vóór aanvang van de metingen voor maaglediging in de uitgangssituatie en dat de sonde niet naar het duodenum is opgeschoven. Het gebruik van claritromycine voor welke indicatie ook wordt niet uitgesloten. 6. QT interval gecorrigeerd met behulp van de Fridericia’s formule (QTcF) > 480 msec op een 12-lead ECG gedurende de screening. 7. De klinische toestand van de patient verslechtert snel, of de onderzoeker is van mening is er een redelijke verwachting dat de patiënt de studie niet zullen voltooien. 8.Childs C cirrose of ALT ≥ 1000 U / l.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    The daily average (mean) percentage of daily protein prescription (DPP) through enteral nutrition by mechanically ventilated and tube-fed patients with EFI, Efficacy Phase Days 1 through 5.
    Primaire eindpunt: De dagelijkse gemiddelde percentage van het dagelijkse eiwit voorschrift (DEV) ontvangen via enterale voeding door de kunstmatig beademde en sondevoeding-gevoede patiënten met EFI, Effectiviteitsfase Dagen 1 tot en met 5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 5
    Dag 1 tot Dag 5
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoint: The daily average (mean) percentage of daily caloric prescription (DCP) received through enteral nutrition by mechanically ventilated and tube-fed patients with EFI, Efficacy Phase Days 1 through 5
    De dagelijkse gemiddelde percentage van het dagelijkse calorieen voorschrift (DCV) via enterale voeding door de kunstmatig beademde en sondevoeding-gevoede patiënten met EFI, Effectiviteitsfase Dagen 1 tot en met 5
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1 through Day 5
    Dag 1 tot Dag 5
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Observation phase Objective: To explore factors associated with the progression of at-risk patients to EFI
    Doel van de Observatiefase: Het onderzoeken van de factoren geassocieerd met de progressie van patiënten die risico lopen op sondevoeding intolerantie.
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Metoclopramide
    Metoclopramide
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Netherlands
    Spain
    United States
    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
    LVLS
    laatste patient laatste visite
    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 years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    ICU patients
    patiënten van de intensive care unit
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 120
    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)
    None
    Geen
    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 Decision2016-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-09
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