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    Summary
    EudraCT Number:2022-000408-36
    Sponsor's Protocol Code Number:08440012010002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-09-11
    Trial 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 number2022-000408-36
    A.3Full title of the trial
    OMAMA-study – prevention of opioid-induced constipation in patients with advanced cancer
    OMAMA-studie - voorkomen van opioïde-geïnduceerde obstipatie in patiënten met gevorderde kanker
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of opioid-induced constipation in patients with advanced cancer
    Voorkomen van obstipatie als gevolg van gebruik van morfine-achtige pijnstillers bij patiënten met pijn bij gevorderde kanker
    A.3.2Name or abbreviated title of the trial where available
    OMAMA-study
    Voorkomen van opioïde-geïnduceerde obstipatie
    A.4.1Sponsor's protocol code number08440012010002
    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 SponsorZonMw
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU university medical center
    B.5.2Functional name of contact pointTrial Office
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204444254
    B.5.6E-mailtrialoffice-onc@vumc.nl
    D. IMP Identification
    D.IMP: 1
    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 MOVICOLON Naturel 13,7 g, poeder voor drank
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine Healthcare B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 powder in sachet
    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: 2
    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 Magnesiumhydroxide Teva 724 mg, kauwtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Chewable tablet
    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
    Opioid-induced constipation in patients with advanced cancer, starting with opioids for pain
    Opioïd-geïnduceerde obstipatie in patiënten met gevorderde kanker, die starten met opioïden voor pijn
    E.1.1.1Medical condition in easily understood language
    Constipation caused by morphine-like agents in patients with advanced cancer who are treated for pain
    obstipatie veroorzaakt door morfine-achtige middelen in patiënten met gevorderde ongeneeslijke kanker die behandeld worden voor pijn
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10071128
    E.1.2Term Opioid induced 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
    In patients with advanced cancer, starting with opioids for pain:
    • To prove non-inferiority of magnesium hydroxide to macrogol/electrolytes in the prevention of OIC, based on the percentage of patients without obstipation (BFI-score <30) after 14 days of treatment
    Bij patiënten met gevorderde kanker, die beginnen met opioïden voor pijn:
    • Het aantonen van non-inferioriteit van magnesiumhydroxide aan macrogol/elektrolyten bij de preventie van OIC, gebaseerd op het percentage patiënten zonder obstipatie (BFI-score <30) na 14 dagen behandeling.
    E.2.2Secondary objectives of the trial
    In patients with advanced cancer, starting with opioids for pain:
    • To compare magnesium hydroxide with macrogol/electrolytes with regard to the Rome IV criteria after 14 days of treatment;
    • To compare magnesium hydroxide with macrogol/electrolytes with regard to quality of life (as measured with the EQ5D) after 14 days of treatment;
    • To compare magnesium hydroxide with macrogol/electrolytes with regard to side effects and patient satisfaction with laxative after 14 days of treatment;
    • To compare magnesium hydroxide with macrogol/electrolytes with regard to difference in pain score between laxative treatment after 14 days of treatment;
    • To compare magnesium hydroxide with macrogol/electrolytes with regard to comparative cost-effectiveness;
    • To predict non-resp[onders by gender, age, BMI, site of cancer, site of metastases and use of medication.
    Bij patiënten met gevorderde kanker, die beginnen met opioïden voor pijn:
    • Het vergelijken van magnesiumhydroxide met macrogol/elektrolyten met betrekking tot de Rome IV-criteria na 14 dagen behandeling;

    • Het vergelijken van magnesiumhydroxide met macrogol/elektrolyten wat betreft kwaliteit van leven (gemeten met de EQ5D) na 14 dagen behandeling;

    • Het vergelijken van magnesiumhydroxide met macrogol/elektrolyten met betrekking tot bijwerkingen en patiënttevredenheid met het laxeermiddel na 14 dagen behandeling;

    • Het vergelijken van magnesiumhydroxide met macrogol/elektrolyten met betrekking tot verschil in pijnscore tussen de laxerende behandelingen na 14 dagen behandeling;

    • Het vergelijken van magnesiumhydroxide met macrogol/elektrolyten met betrekking tot kosteneffectiviteit;

    • Het voorspellen van non-responders op geslacht, leeftijd, BMI, plaats van kanker, plaats van metastasen en medicijngebruik.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    • Patients with advanced cancer (≥18 years);
    • Starting with slow release or transdermal opioids for pain;
    • Able to complete a Dutch questionnaire.
    Previous treatment with opioids is allowed, if discontinued more than 4 weeks ago
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een proefpersoon aan alle volgende criteria voldoen:
    • Patiënten met gevorderde kanker (≥18 jaar);
    • Beginnen met langzame afgifte of transdermale opioïden voor pijn;
    • Een Nederlandse vragenlijst kunnen invullen.
    Eerdere behandeling met opioïden is toegestaan, mits meer dan 4 weken geleden gestopt.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Patients with contra-indications for laxatives
    • Maintenance treatment with laxatives during the last two weeks
    • Severely impaired renal function (serum creatinine >180 umol/l)
    • Estimated life expectancy <1 month
    Een potentiële proefpersoon die aan een van de volgende criteria voldoet, wordt uitgesloten van deelname aan dit onderzoek:
    • Patiënten met contra-indicaties voor laxeermiddelen
    • Onderhoudsbehandeling met laxantia in de laatste 2 weken
    • Ernstig verminderde nierfunctie (serumcreatinine >180 umol/l)
    • Geschatte levensverwachting <1 maand
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is constipation, defined as the percentage of patients with a score of <30 of the Bowel Function Index
    Het primaire eindpunt is obstipatie, gedefinieerd als het percentage patiënten met een score van <30 van de Bowel Function Index
    E.5.1.1Timepoint(s) of evaluation of this end point
    On day 14
    Op dag 14
    E.5.2Secondary end point(s)
    Secondary endpoints
    • Change of the Bowel Function Index Score between day 0 and day 14;
    • Quality of life;
    • Rome IV criteria for opioid-induced constipation as judged by professional care givers
    • Cancer pain score
    • Patient satisfaction with laxative;
    • Side effects of laxatives;
    • Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide.
    • Verandering van de Bowel Function Index Score tussen dag 0 en dag 14;
    • Kwaliteit van het leven;
    • Rome IV-criteria voor opioïde-geïnduceerde obstipatie zoals beoordeeld door professionele zorgverleners
    • Kankerpijnscore
    • Patiënttevredenheid met laxeermiddel;
    • Bijwerkingen van laxeermiddelen;
    • Kosteneffectiviteit van macrogol/elektrolyten in vergelijking met magnesiumhydroxide
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints
    • Change of the Bowel Function Index Score between day 0 and day 14: day 0 and 14
    • Quality of life: day 0 and 14
    • Rome IV criteria for opioid-induced constipation as judged by professional care givers: day 0 and 14
    • Cancer pain score: day 0 and 14
    • Patient satisfaction with laxative: day 14
    • Side effects of laxatives: day 14
    • Cost-effectiveness of macrogol/electrolytes compared to magnesium hydroxide: day 14
    • Verandering van de Bowel Function Index Score tussen dag 0 en dag 14: dag 0 en 14
    • Kwaliteit van het leven: dag 0 en 14
    • Rome IV-criteria voor opioïde-geïnduceerde obstipatie zoals beoordeeld door professionele zorgverleners: dag 0 en 14
    • Kankerpijnscore: dag 0 en 14
    • Patiënttevredenheid met laxeermiddel: dag 14
    • Bijwerkingen van laxeermiddelen: dag 14
    • Kosteneffectiviteit van macrogol/elektrolyten in vergelijking met magnesiumhydroxide: dag 14
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    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 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 No
    E.8.2.3Other No
    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 concerned13
    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 end of the study is defined as the last patient’s last visit.
    Het einde van het onderzoek wordt gedefinieerd als het laatste bezoek van de laatste patiënt.
    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 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with incurable diseases
    patiënten met een ongeneeslijke ziekte
    F.4 Planned number of subjects to be included
    F.4.1In the member state330
    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 Decision2022-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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