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    Summary
    EudraCT Number:2017-003830-97
    Sponsor's Protocol Code Number:OS-PCC-2017
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-003830-97
    A.3Full title of the trial
    Effects of an Opiod Sparing Care Pathway for Patients undergoing Obesity Surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of an Opiod Sparing Care Pathway for Patients undergoing Obesity Surgery
    A.3.2Name or abbreviated title of the trial where available
    OS-PCC study
    A.4.1Sponsor's protocol code numberOS-PCC-2017
    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 SponsorSahlgrenska University Hospital
    B.1.3.4CountrySweden
    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 supportSahlgrenska universitetssjukhuset område 2 verksamhetsområde Anestesi/Operation/Intensivvård
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital
    B.5.2Functional name of contact pointSven-Egron Thörn
    B.5.3 Address:
    B.5.3.1Street AddressVerksamhetsomr. Anestesi/Operation/Intensivvård, Sahlgrenska Universitetssjukus, Östra Sjukhuset
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code41650
    B.5.3.4CountrySweden
    B.5.4Telephone number46313434903
    B.5.6E-mailsvenegron.thorn@vgregion.se
    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 Dexdor
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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
    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 INNDEXMEDETOMIDINE
    D.3.9.1CAS number 113775-47-6
    D.3.9.4EV Substance CodeSUB07037MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Ketanest
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    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 Infusion
    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 INNESKETAMINE
    D.3.9.1CAS number 33643-46-8
    D.3.9.4EV Substance CodeSUB25825
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Lidokain Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Hospital AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 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 INNLidokain Mylan
    D.3.9.1CAS number 6108-05-0
    D.3.9.3Other descriptive nameLIDOCAINE HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB02922MIG
    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.IMP: 4
    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 Ultiva
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline AB
    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 Concentrate and solvent for solution for injection/infusion
    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 INNUltiva
    D.3.9.3Other descriptive nameREMIFENTANIL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04215MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    See below
    Utvärdera effekterna av en opiodsparande, personcentrerad vårdväg för patienter som genomgår obesitas kirurgi
    E.1.1.1Medical condition in easily understood language
    See below
    Utvärdera effekterna av en opiodsparande, personcentrerad vårdväg för patienter som genomgår obesitas kirurgi
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059610
    E.1.2Term Obesity surgery
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    See below
    Att utvärdera effekterna av opiodsparande behandlingar jämförd med konventionell opiodbaserad behandling med avseende på smärtlindring, återhämtning, tilltro till sin egen förmåga (Self-Efficacy) samt vårdtid hos patienter som genomgår fetmaoperation med titthålskirurgi.
    E.2.2Secondary objectives of the trial
    "Not applicable"
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    See below
    •Pat ≥18 år som ska genomgå laparoskopisk fetmaoperation (GBP alt Sleeve)
    •Ge sitt samtycke att ingå i studien
    E.4Principal exclusion criteria
    See below
    •ASA > 3, Kranskärlssjukdom eller kärlkramp med bradykardi ( < 50 slag/min).
    •Alvarlig leversvikt
    •Behov av tolk
    •Allvarlig obehandlad psykiatrisk sjukdom inklusive psykiatriska och eller psykologiska sjukdomar
    •Neurokognitiv dysfunktion enlig journal
    •Graviditet
    •Kvinnor i fertil ålder utan preventivmedel
    •Malign sjukdom och förväntad kort överlevnad
    •Pat som behandlas med Opioder eller psykofarmaka för långvarigt smärttillstånd
    •Substansmissbruk
    •Överkänslighet mot Oxycodone, Esketamin, Dexmedetomidine alt Lidocain
    •Pacemaker och ICD
    •Oförmåga att fylla i frågeformulär
    •Vill ej deltaga
    E.5 End points
    E.5.1Primary end point(s)
    See below
    Skillnad i patientrapporterad smärta mätt som skillnad i patientrapporterad smärta enligt NRS från ankomst från operation till post-operativ enhet till utskrivning till avdelningen. Max deviation för att anses vara non-inferior i NRS är satt till non-inferiority margin -1 NRS (CL 95%, SD 1,62), beräknad som skillnad i NRS ankomst (inom 30 min efter ankomst till post-op) till utskrivningsklar från post-op. NRS (numeric rating scale for pain) senaste 24 timmarna (skala 0-10, ”ingen smärta” vs. ”värsta tänkbara smärta”)
    E.5.1.1Timepoint(s) of evaluation of this end point
    See below
    •NRS mäts från ankomst till post-operativ enhet till utskrivning från post-operativ enhet.
    E.5.2Secondary end point(s)
    See below
    En opiodsparande behandling ger:
    •förbättrad kombinerad utfall (composite score) beståendes av 1) General Self Efficacy Scale (GSES) [1], 2) Postop Quality of Recovery Scale (PQRS)[2], återinläggning på sjukhus alt död i jämförelse mellan interventionspatienter och konventionell behandling efter 3 månader.
    •minskad opiodkonsumtion perio- och postoperativt (räknat till utskrivning till avdelning från uppvakningsenheten) i jämförelse med konventionell behandling.
    •minskad opiodkonsumtion under hela sjukhustiden i jämförelse mellan interventionspatienter och konventionell behandling.
    •minskad smärtupplevelse enligt NRS efter 3 månader samt efter 6 månader i jämförelse mellan interventionspatienter och konventionell behandling.
    •en tidigare återhämtning efter operation mätt med PQRS jämförd med konventionell behandling postoperativt (20 min, 40 min), under sjukhustiden (24 -72 timmar) samt efter hemgång (14 dagar, 30 dagar, 3 mån, 6 månader, 12 mån samt 24 månader).
    •ökad tilltro till sin egen förmåga att klara oväntade händelser mätt med GSES jämförelse med konventionell behandling under sjukhustiden (3 mån, 6 månader, 12 månader, 24 månader).
    •ökad livskvalitet mätt med RAND-36 samt EQ5D i jämförelse med konventionell behandling under sjukhustiden (3 mån, 6 månader, 12 månader, 24 månader).
    •likvärdig vårdtid jämförelse med konventionell behandling under sjukhustiden.

    Kartläggning av långtidsförskrivning av smärtstillande preparat. Påverkar opiodsparande behandling långtidsanvändningen av smärtstillande läkemedel.

    E.5.2.1Timepoint(s) of evaluation of this end point
    See below
    •Telefonstöd en gång per vecka under 4 veckor efter hemgång (Intervention Fas 2) (Hälsotillstånd just nu, Upplevelser av smärta samt smärtbehandling (TENS), Patientens egna frågor och funderingar samt Upplevelsen av vårdförloppet.)
    •Enkätuppföljning:
    PQRS: Preoperativ samtal, baseline, postoperativt enligt schema 20 min, 40 min, 24 -72 timmar, 14 dagar, 30 dagar, 3 mån, 6 månader, 12 mån samt 24 månader.
    RAND Short Form 36, EQ5D, Sheehan Disability Scale samt GSE: baseline, 3 mån, 6 månader, 12 månader, 24 månader.
    PPP 15: 2 veckor efter utskrivning.
    Hälsoekonomi: baseline, 30 dagar, 3 mån, 6 månader, 12 månader, 24 månader

    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 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) 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 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) 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
    See below
    Studien är avslutat när sista patienten har följts upp (efter 24 månader)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    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 state220
    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 Decision2018-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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