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    Summary
    EudraCT Number:2016-001143-40
    Sponsor's Protocol Code Number:OBEMO1EXT
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001143-40
    A.3Full title of the trial
    Long-term effects of Roux-en-Y Gastric Bypass on morphine exposure after oral administration of immediate release morphine, in comparison with subjects without surgery
    Impact à long terme du bypass gastrique sur l’exposition de la morphine après administration de morphine à libération immédiate, en comparaison à des sujets non opérés
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of blood concentrations of morphine after oral administration of immediate release morphine in subject who have undergone a bariatric surgery called Roux-en-Y Gastric Bypass for a long time, in comparison with subjects who did not undergo surgery.
    Etude des concentrations de la morphine à libération immédiate après administration par voie orale de morphine à libération immédiate chez des sujets opérés d'une chirurgie de l'obésité appellée bypass gastrique
    A.3.2Name or abbreviated title of the trial where available
    OBEMO 1 Extension
    OBEMO 1 Extension
    A.4.1Sponsor's protocol code numberOBEMO1EXT
    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 SponsorTherapeutic Research Unit
    B.1.3.4CountryFrance
    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 supportResearch fund
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTherapeutic Research Unit
    B.5.2Functional name of contact pointLLORET-LINARES
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Lariboisière, 2 rue Ambroise Paré
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33149958127
    B.5.5Fax number33149958446
    B.5.6E-mailcelialloret@yahoo.fr
    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 ORAMORPH
    D.2.1.1.2Name of the Marketing Authorisation holderL. MOLTENI & C. DEI F. LLI ALITTI SOCIETA DI ESERCIZIO S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameORAMORPH 30 mg/5 ml
    D.3.4Pharmaceutical form Oral solution in single-dose container
    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
    Subjects volunteers who undergone Roux-en-Y gastric bypass (RYGB) for at least 48 months
    and control subjects matched for BMI, age and sex
    Sujets volontaires opérés d'un bypass gastrique (RYGB) depuis au moins 48 mois
    et sujets contrôles appariés sur l'indice de masse corporelle (IMC), l'age et le sexe
    E.1.1.1Medical condition in easily understood language
    Subjects who undergone bariatric surgery called Roux-en-Y gastric bypass (RYGB) for at least 48 months
    and control volunteers matched for body size, age and sex who did not undergo bariatric surgery
    Sujets volontaires opérés d'une chirurgie de l'obésité nommée bypass gastrique (RYGB) depuis au moins 48 mois
    et sujets contrôles volonatires appariés sur la corpulence, l'age et le sexe
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    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 morphine exposition (AUC0-inf) after oral administration of immediate release morphine sulfate, 30mg, in patients who undergone Roux-en-Y Gastric Bypass with morphine exposition in patients who did not, matched for age, sex and Body Mass Index.
    Comparer l’exposition (AUC0-inf) de la morphine après administration orale de morphine à LI 30mg chez des sujets ayant bénéficié d’une chirurgie de type RYGB depuis au moins 48 mois à celle de sujets n’ayant pas été opéré, appariés sur le sexe, l’âge et l’indice de masse corporelle.
    E.2.2Secondary objectives of the trial
    To compare the other pharmacokinetics parameters of morphine and morphine metabolites, M3G and M6G, between RYGB and control populations (Cmax, Tmax, Cl/F, Vdz/F, clearance et T1/2 et AUC 0-inf).
    Specify morphine pharmacokinetic parameters evolution from before surgery, at 1-2 weeks, 6 months and 48 years after surgery
    Comparer les autres paramètres pharmacocinétique de la morphine et de ses métabolites, la M3G et la M6G, entre sujets opérés et non opérés (Cmax, Tmax, Cl/F, Vdz/F, clairance et T1/2 et AUC 0-inf).
    Décrire l’évolution des paramètres PK de la morphine entre les différentes périodes d’étude à savoir avant la chirurgie, entre 1 à 2 semaines après la chirurgie, 6 mois après et à 4 ans.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    RYGB Group (n=12)
    -Subjects who undergone RYGB for at least 48 months included in OBEMO1 ans OBEMO2
    - Stable weight since almost one year (or weight loss below 10kg over the last year)

    Control group (n=12)
    -Volunteers subjects, matched for age, sex, and Body mass index
    -No history of bariatric surgery

    Same characteristics
    -Subjects volunteers for the study
    -Age 20-70 years
    -Written consent
    - Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) < 2
    Groupe RYGB (n=12)
    - Sujets opérés d’un RYGB depuis au moins 48 mois et ayant participé à l’étude OBEMO1 et OBEMO2.
    - Poids stabilisé depuis au moins une année (perte ou prise de poids inférieure à 10kg sur une année, période survenant habituellement au minimum deux années après la chirurgie)

    Groupe contrôle (n=12)
    - Sujets volontaires appariés sur l’âge, le sexe et l’indice de masse corporelle (poids (kg)/taille (m2)) aux sujets opérés
    - Absence d’antécédent de chirurgie de l’intestin avec résection

    Caractéristiques communes
    - Sujets volontaires pour cette étude
    - Age d’inclusion entre 20 et 70 ans
    - Consentement éclairé et écrit
    - Score d’addiction à une substance selon les critères Diagnostic and Statistical Manual of Mental Disorders (DSM-5) < 2
    E.4Principal exclusion criteria
    - Individuals under the protection of a conservaor, curatorship, guardianship
    -Uncontrolles seizures
    -Known allergy to morphine or naloxone
    -Patients not affiliated to the french social security system.
    -Subjects yet recruited in a study with remuneration
    -Abnormalities in liver function (TP<70%and/or ASAT>5N and/or ALAT>5N) and/or in renal function (creatinine clearance MDRD<60ml/min)
    - Respiratory insufficiency defined by an oxigen saturation below 90%.
    -Pregnancy and breastfeeding
    -Use of drugs contra-indicated or not advised with morphine:
    •Agonists-antagonists Opioids (buprenorphine, nalbuphine, pentazocine), Naltrexone
    •Alcohol intake> 30g by day
    •Cough medicine morphine-like (dextromethorphan, noscapin, pholcodin)
    • Codeine, éthylmorphine
    •Other morphine agonists (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidin, remifentanil, sufentanil, tramadol)
    •Barbiturates, Benzodiazepines.
    •Rifampicin
    - Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) ≥ 2
    Morphine/ opiate addiction or abuse, or history of morphine/ opiate addiction or abuse
    - Sujets sous tutelle, curatelle, sauvegarde de justice
    - Epilepsie non contrôlée
    - Hypersensibilité connue à la morphine, à la naloxone, au métoclopramide, au paracétamol, au phloroglucinol ou à leurs excipients.
    - Non affiliation à un régime de sécurité sociale (bénéficiaires ou ayant droit).
    - Sujet participant déjà à une étude rémunérée
    - Anomalies du bilan hépatique (TP<70%et/ou ASAT>5N et/ou ALAT>5N) et/ou rénale (clairance de la créatinine selon Cockroft & Gault et MDRD<60ml/min)
    - Insuffisance respiratoire, définie par une saturation en oxygène mesurée par oxymétrie inférieure à 90%
    - Grossesse et allaitement
    - Utilisation de substances contre indiquées ou déconseillées avec l’utilisation de morphine :
    • Morphiniques agonistes-antagonistes (buprénorphine, nalbuphine, pentazocine), Naltrexone
    • Consommation d'alcool> 30g/jour
    • Antitussifs morphine-like (dextrométhorphane, noscapine, pholcodine)
    • Antitussifs morphiniques vrais (codéine, éthylmorphine)
    • Autres analgésiques morphiniques agonistes (alfentanil, codéine, dextromoramide, dextropropoxyphène, dihydrocodéine, fentanyl, oxycodone, pethidine, phénopéridine, remifentanil, sufentanil, tramadol)
    • Barbituriques, Benzodiazépines et apparentés.
    • Rifampicine
    - Score d’addiction à une substance selon les critères Diagnostic and Statistical Manual of Mental Disorders DSM ≥ 2
    - Contexte ou antécédent d’abus ou de dépendance à la morphine, aux dérivés opiacés
    E.5 End points
    E.5.1Primary end point(s)
    To compare morphine exposition (AUC0-inf) after oral administration of immediate release morphine sulfate, 30mg, in patients who undergone bariatric surgery with morphine exposition in patients who did not, matched for age, sex and Body Mass Index.
    Il s’agit de l’aire sous la courbe de la morphine (AUC0-inf) après l’administration orale de 30 mg de sulfate de morphine à libération immédiate à partir des dosages plasmatiques de morphine, dans les deux groupes de sujets.
    E.5.1.1Timepoint(s) of evaluation of this end point
    plasma samples are collected before and at 5min; 15min; 30 min; 45 min; 1h; 2h; 3h; 4h; 6h; 8h; 10 h after administration of morphine; one time during the study visit
    Les prélèvements plasmatiques pour les dosages de morphine, M3G et M6G auront lieu auront lieu sur 10 heures: 12 prélèvements sont réalisés aux temps suivants (heures après l’administration de morphine) : T0 – 5min – 15min – 30 min – 45 min – 1h – 2h – 3h – 4h –6h – 8h – 10 h
    E.5.2Secondary end point(s)
    Other pharmacokinetic parameters of morphine and its metabolites M3G and M6G (Cmax, Tmax, Cl/F, Vdz/F, clearance, T1/2 and AUC0-inf) in both study group and other pharmacokinetics parameters gotten in these patients in OBEMO1 study.
    Les autres paramètres pharmacocinétiques de la morphine orale, du M3G et de la M6G (Cmax, Tmax, Cl/F, Vdz/F, clairance et T1/2 et AUC0-inf) dans les deux groupes de sujets, et tous les autres paramètres pharmacocinétiques obtenus lors de l’étude OBEMO1 chez les mêmes patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    plasma samples are collected at T0 – 5min – 15min – 30 min – 45 min – 1h – 2h – 3h – 4h –6h – 8h – 10 h after administration of morphine; one time during the study visit
    Urine sample collected during the study visit from the time of administration of morphine to T10h
    Les prélèvements plasmatiques pour les dosages de morphine, M3G et M6G auront lieu auront lieu sur 10 heures: 12 prélèvements sont réalisés paux temps suivants (heures après l’administration de morphine) : T0 – 5min – 15min – 30 min – 45 min – 1h – 2h – 3h – 4h –6h – 8h – 10 h
    - Le recueil des urines du sujet pour les dosages de morphine, M3G et M6G aura aussi lieu sur 10 heures
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    The study for a given patient will end the day of the pharmacokinetic study. The patient can be included until 4 months before the PK visit.
    The study will end once having performed the PK studies for the 24 patients
    L'étude pour un patient donné s'achève le jour de l'étude pharmacocinétique. Le patient peut être inclus jusque 4 mois avant cette étude PK.
    L'étude sera achevée une fois les PK des 24 patients réalisée.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state24
    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
    Aucun
    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 Decision2016-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
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