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    Summary
    EudraCT Number:2018-005006-62
    Sponsor's Protocol Code Number:ASZ-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-14
    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 number2018-005006-62
    A.3Full title of the trial
    Pharmacokinetics of Paracetamol before and after Roux-en-Y gastric bypass
    Farmacokinetiek van paracetamol voor en na Roux-en-Y gastric bypass
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The amount of paracetamol in blood before and after a gastric bypass procedure
    Hoeveelheid paracetamol in het bloed voor en na een maagverkleinende operatie
    A.3.2Name or abbreviated title of the trial where available
    PAPAYA
    A.4.1Sponsor's protocol code numberASZ-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 SponsorAlbert Schweitzer hospital
    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 supportScientific Fund of Albert Schweitzer hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlbert Schweitzer hospital
    B.5.2Functional name of contact pointHospital Pharmacy
    B.5.3 Address:
    B.5.3.1Street AddressAlbert Schweitzerplaats 25
    B.5.3.2Town/ cityDordrecht
    B.5.3.3Post code3318 AT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31786523213
    B.5.6E-mails.f.lau@asz.nl
    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 Paracetamol
    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.3.1Product nameParacetamol
    D.3.4Pharmaceutical form Tablet
    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 INNparacetamol
    D.3.9.1CAS number 103-90-2
    D.3.9.2Current sponsor codeparacetamol
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Paracetamol
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi 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.3.1Product nameParacetamol
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNparacetamol
    D.3.9.1CAS number 103-90-2
    D.3.9.2Current sponsor codeparacetamol
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Roux-en-Y gastric bypass
    Roux-en-Y gastric bypass
    E.1.1.1Medical condition in easily understood language
    Gastric bypass
    Maagverkleinende operatie
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033762
    E.1.2Term Paracetamol
    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 assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol before the surgery. within one month after the surgery and 6 months after the surgery.
    Beschrijven van het effect van RYGB op de farmacokinetiek van een eenmalige orale gift van 1000 mg PCM, voorafgaand aan de ingreep, binnen de eerste maand na ingreep en 6 maanden erna.
    E.2.2Secondary objectives of the trial
    To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of the metabolites paracetamol glucuronide (PCM-GLU), paracetamol sulfate (PCM-SUL), paracetamol mercatopurate (PCM-MER) and paracetamol cysteine (PCM-CYS) after a single oral dose of 1000 mg paracetamol before the surgery, within one month after the surgery and 6 months after the surgery.

    To assess the effect of a single dose of 1000 mg paracetamol on aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (γ-GT) and bilirubin after 6 and 24 hours of oral intake of paracetamol before and after Roux-en-Y gastric bypass
    Secundair wordt de farmacokinetiek van de metabolieten paracetamolglucuronide (PCM-GLU), paracetamolsulfaat (PCM-SUL), paracetamolmercatopuraat (PCM-MER) en paracetamolcysteïne (PCM-CYS) bestudeerd na een eenmalige orale gift van 1000 mg paracetamol.

    Nagaan wat het effect is van een eenmalige gift van 1000 mg paracetamol oraal op aspartaat aminotransferase (ASAT), aminiotransferase (ALAT), gamma-glutamyltransferase (γ-GT) en bilirubine na 6 uur na inname van paracetamol voor en na RYGB.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - at least 18 years old
    - on the waiting list of getting a Roux-en-Y gastric bypass
    - mentally competent
    - provided informed consent
    - ten minste 18 jaar oud
    - op de wachtlijst om een RYGB te ondergaan
    - wilsbekwaamheid
    - informed consent gegeven
    E.4Principal exclusion criteria
    - to undergo gastric band, gastric sleeve, mini gastric bypass or revision RYGB
    - to undergo procedures for gastric band, RYGB or gastric sleeve previously
    - taken paracetamol < 24 h before blood sampling at t=0
    - allergy or intolerance for paracetamol
    - not being able to take paracetamol orally
    - to vomit after intake of paracetamol
    - to be pregnant
    - ondergaan van maagband, gastric sleeve, mini gastric bypass of revisie RYGB operatie
    - eerdere maagband, RYGB of gastric sleeves ondergaan
    - PCM < 24 uur ingenomen voor bloedafname PCM tijdstip t=0 min
    - allergie of overgevoeligheid voor PCM
    - niet oraal kunnen innemen van PCM
    - braken na inname van PCM
    - zwanger
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the pharmacokinetics of paracetamol after a single oral dose of 1000 mg before and after RYGB.
    De primaire uitkomstmaat is de farmacokinetiek van paracetamol na een eenmalige orale gift van paracetamol 1000 mg voor en na RYGB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end point is determined at maximally 2 months before Roux-en-Y gastric bypass (RYGB) and at weeks - 1 month and 5-7 months after RYGB.
    Het eindpunt wordt maximaal 2 maanden voor Roux-en-Y gastric bypass (RYGB) bepaald, en vervolgens op 2 weken - 1 maand en 5-7 maanden na RYGB.
    E.5.2Secondary end point(s)
    Secondary end point is the pharmacokinetics of the metabolites (paracetamol glucuronide, paracetmol sulfate, paracetamol mercatopurate and paracetamol cysteine) after a single oral dose of 1000 mg paracetamol before and after RYGB

    Additional secondary end points are ASAT, ALAT, γ-GT and bilirubin values.
    Secundaire uitkomstmaat is de farmacokinetiek van de metabolieten (paracetamolglucuronide, -sulfaat, -mercaptopuraat, en -cysteine)

    Aanvullende secundaire uitkomstmaten zijn ASAT- en ALAT, γ-GT en bilirubinewaarden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The pharmacokinetic profiles are determined at maximally 2 months before Roux-en-Y gastric bypass (RYGB) and at weeks - 1 month and 5-7 months after RYGB.

    The liver values are determined at T=0, T=6 h and T=24 h at each of the timepoints at which a plasma-concentration curve is measured.
    De farmacokinetische profielen worden maximaal 2 maanden voor Roux-en-Y gastric bypass (RYGB) bepaald, en vervolgens op 2 weken - 1 maand en 5-7 maanden na RYGB.

    De leverwaarden worden op T=0, T=6 uur en T=24 uur bepaald op ieder van de meetmomenten van een plasma-concentratie curve.
    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 No
    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 No
    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 Yes
    E.8.2.3.1Comparator description
    gezonde vrijwilligers zonder overgewicht
    healthy volunteers without overweight
    E.8.2.4Number of treatment arms in the trial1
    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
    laatste visite van de laatste deelnemer
    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 months10
    E.8.9.1In the Member State concerned days
    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: 28
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state28
    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 Decision2019-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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