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    Summary
    EudraCT Number:2014-004687-37
    Sponsor's Protocol Code Number:14SM2335
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-004687-37
    A.3Full title of the trial
    Use of Methylnaltrexone for the Treatment of Opioid Induced Constipation & Gastro-Intestinal Stasis in Intensive Care Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methylnaltrexone for the Treatment of Opioid drug Induced Constipation (MOTION Study)
    A.3.2Name or abbreviated title of the trial where available
    Methylnaltrexone for the Treatment of Opioid Induced Constipation
    A.4.1Sponsor's protocol code number14SM2335
    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 SponsorImperial College Healthcare NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR - Research for Patient Benefit Programme (RfPB)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College Healthcare NHS Trust
    B.5.2Functional name of contact pointParind Patel
    B.5.3 Address:
    B.5.3.1Street AddressGeneral Intensive Care Unit, Hammersmith Hospital, DuCane Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 0HS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02083831878
    B.5.6E-mailparind.patel@imperial.nhs.uk
    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 Relistor
    D.2.1.1.2Name of the Marketing Authorisation holderTMC Pharma Services Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRelistor
    D.3.4Pharmaceutical form Solution for injection
    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 INNMethylnaltrexone bromide
    D.3.9.1CAS number 73232-52-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Opioid Induced Constipation
    E.1.1.1Medical condition in easily understood language
    Constipation
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    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 assess the efficacy of methylnaltrexone in producing laxation in patients sedated with opioid infusions.
    E.2.2Secondary objectives of the trial
    1. To assess if the use of methylnaltrexone leads to increased opioid requirements through CNS penetration and antagonism

    2. To assess if there are additional benefits from preventing constipation such as reduced gastric stasis, improved enteral feeding, and a reduction in infection

    3. To assess the safety and side effect profile of intravenous methylnaltrexone in ICU patients

    4. Blood will further analysed and stored for:
    • Cytokine levels
    • Leucocyte function assays
    • Metabolic profiles
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Males and females ≥ 18 years of age
    • Following ICU admission, sedated with opioids and requiring invasive ventilator support
    • Scheduled for continuous infusion/administration of opioid analgesics for at least a further 24 hours
    • Constipated (not opened bowels for a minimum 48 hours following ICU admission)
    • Access for enteral administration of medications and nasal-gastric tube feeds
    • Initiation of nasogastric tube feeds
    • Patient weight of 38-114kg (this allows pre preparation of drug with either 8mg or 12mg)
    E.4Principal exclusion criteria
    • Known to be pregnant
    • Patients with end stage renal failure requiring dialysis on admission
    • Diarrhoea on admission
    • Abdominal surgery within 8 weeks prior to ICU admission
    • Presence of Ileostomy or colostomy
    • Mechanical gastrointestinal obstruction
    • Suspected Acute surgical abdomen
    • History of Crohn's disease or ulcerative colitis
    • On Palliative care or not expected to survive more than 12 hours
    • Severe chronic hepatic impairment (Child Pugh Class C)
    • Suspected hepatic encephalopathy
    • Known to have received another IMP within 30 days or currently in another interventional trial that might interact with the study drug or previously enrolled into MOTION
    E.5 End points
    E.5.1Primary end point(s)
    Time to rescue-free opening bowels following randomisation. Significant bowel opening is defined as an estimate of stool volume of greater than 100nls by the attending nurse.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 28 days after randomisation.
    E.5.2Secondary end point(s)
    • Gastric Residual Volume measured every 4 hours and totalled over 24 hours
    • Toleration of enteral feeds: Daily assessment of % of patients achieving full target enteral feeding
    • Requirement of rescue laxatives (1/2 sachet picolax, 2 glycerin suppositories)
    • Requirement of prokinetics (10mg metoclopramide tds, 250mg erythromycin qds)
    • Average number of bowel movements per day
    • Escalation of opioid dose due to antagonism/reversal of analgesia and sedation
    • Incidence of ventilator associated pneumonia (VAP), defined by the Clinical Pulmonary Infection Score (CPIS)
    • Incidence of diarrhoea
    • Incidence of Clostridium difficile infection: PCR or Toxin positive
    • Incidence of positive microbiology blood cultures
    • Mortality: 28 day, ICU and Hospital

    Secondary mechanistic Outcomes:
    • Sepsis Biomarkers
    • Leucocyte Function Tests
    • Leucocyte Migration Assays
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily througout trial and up to 28 days after randomisation.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 end when the specified numbers of patients (84) have been recruited, the last patient has been discharged from hospital (or a maximum of 3 months from randomisation of the last patient), and the database is locked.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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
    Patients will be sedated and therefore unable to consent for themselves. Consent will be obtained from a Personal or Professional Legal Representative as described elsewhere.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    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)
    The study duration and impact will be whilst the patient is on ICU. It is not anticipated that patients would leave the ICU on opioids. Once the patient has finished the study their treatment will continue as part of routine clinical care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-11
    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 trial2018-02-28
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