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    Summary
    EudraCT Number:2017-002368-42
    Sponsor's Protocol Code Number:LUM-001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-22
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-002368-42
    A.3Full title of the trial
    An open, randomized, controlled, single centre trial to evaluate CT image quality and diagnostic feasibility of Lumentin® 44, a new egg albumen based oral bowel filling agent, in comparison with diluted Omnipaque® and Movprep®, two commonly used agents in subjects referred for abdominal CT-examination.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open, randomized, controlled, single centre trial to evaluate computed tomography image quality and diagnostic feasibility of Lumentin® 44, a new egg white based oral bowel filling contrast agent, and to compare it with two commonly used contrast agents, diluted Omnipaque® and Movprep®.
    A.4.1Sponsor's protocol code numberLUM-001
    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 SponsorLument AB
    B.1.3.4CountrySweden
    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 supportLument AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLument AB
    B.5.2Functional name of contact pointOlof Böök
    B.5.3 Address:
    B.5.3.1Street AddressScheelevägen 22
    B.5.3.2Town/ cityLund
    B.5.3.3Post code220 07
    B.5.3.4CountrySweden
    B.5.6E-mailolof.book@lumentab.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 nameLumentin 44
    D.3.2Product code L 44
    D.3.4Pharmaceutical form Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEgg Albumen Powder
    D.3.9.3Other descriptive nameEGG WHITE PROTEIN
    D.3.9.4EV Substance CodeSUB188408
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeDispersion of egg white protein
    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 Omnipaque, 240 mg I/mL
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare AS
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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.IMP: 3
    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 Movprep
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine BV
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    None.
    Lumentin 44 is a contrast agent and the contrast properties will be investigated in this trial.
    Patients referred to computerised tomography of the abdomen will be included in the trial. Neither their medical condition nor disease will be investigated.
    E.1.1.1Medical condition in easily understood language
    None.
    Lumentin 44 is a contrast agent and its properties will be investigated in this trial.
    Neither patients medical condition nor disease will be investigated.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10011603
    E.1.2Term CT scan
    E.1.2System Organ Class 100000004848
    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 mean difference incontrast density shown on abdominal CT-images when using the contrast agent Lumentin® 44, with abdominal CT-images using diluted Omnipaque® and with abdominal CT-images using Movprep®
    E.2.2Secondary objectives of the trial
    • To describe and compare the ability of Lumentin® 44 to fill the bowel as compared to Movprep® and diluted Omnipaque®.
    • To describe and assess how Lumentin® 44 influences reading of the abdominal CT-examination as compared to Movprep® and diluted
    Omnipaque® with respect to:
    o Diagnostics with particular regard to parenchymal organs, lymphatic system and tissue compartments beyond the gastrointestinal tract
    • To investigate signs of degradation of Lumentin® 44 in terms of
    o Coalesence
    o Syneresis or drainage
    • Describe and compare the ability to eat/drink for each of three contrast agents with respect to:
    o Taste
    o Smell
    o Consistency
    o Ability to swallow
    o Fullness
    • To evaluate safety and tolerability after oral administration of each of three contrast agents
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects of either gender at least 18 years at the time of signing the informed consent.
    2. Females must either present a negative pregnancy test or be surgically sterile (hysterectomy or tubal ligation) or postmenopausal (i.e. experienced 12 consecutive months without menstruation)
    3. Having a clinical indication for CT-examination of the abdomen
    4. Having fasted (drinking allowed) for at least four hours prior to the intake of the contrast agent
    5. Patients participating in concurrent oncology trial must either participate in the follow up phase of the clinical trial and currently receive no trial drug treatment since at least 6 weeks, or receive a reduced maintenance dose of the trial treatment
    6. Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any trial related activity is carried out.
    E.4Principal exclusion criteria
    1. IV administration of iodine is contraindicated
    2. Clinical suspicion, according to medical record, of fistula formation and/or leakage
    3. Having swallowing disorders preventing intake of the contrast agents
    4. Referral indication of small bowel disease(s)
    5. Known allergy to egg albumen
    6. Known sensitivity to any of the components of the investigational product or comparators
    7. Having known manifest thyrotoxicosis
    8. Having known phenylketonuria
    9. Having known Glucose-6-phosphatase deficiency
    10. Has taken any medication, absorbed through the small bowel, less than four hours before intake of the investigational product or comparators
    11. Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol
    12. Previously randomised to participate in this trial
    13. Participating in, or having participated in another, non-oncology clinical trial where the final trial treatment was given within the last 6 weeks
    14. Participating in an oncology clinical trial where the final full (i.e. non-maintenance) trial treatment was given within the last 6 weeks
    E.5 End points
    E.5.1Primary end point(s)
    The mean difference in contrast density in HU, expressed as the mean of 9 measurements of contrast density differences between bowel lumen and wall (mucosal lining) performed in the 5 sub-segments of the small bowel.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1
    E.5.2Secondary end point(s)
    • Bowel filling properties (extension and distension) on Abd-CT in each of 5 sub-segments of the small bowel
    • Degradation (presence of bubbles and signs of sedimentation) on Abd-CT in each of 5 sub-segments of the small bowel
    • Diagnostic ability on Abd-CT of the parenchyma, lymphatic system and tissue compartments beyond the gastrointestinal tract.
    • Subject assessments of taste, smell, consistency, ability to swallow and fullness after swallowing the contrast agent
    • Safety Parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary end points will be evaluated on day 1.
    Safety Parameters will be evaluated on day 1 and between 12 to 48 hours post day 1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned 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: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state88
    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
    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 Decision2017-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-02-15
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