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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2012-001557-46
    Sponsor's Protocol Code Number:01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-001557-46
    A.3Full title of the trial
    Perioperativ installation of ropivacain in mastectomy – with or without axillary lymph node dissection after sentinel node diagnostics or known lymph node metastasis – A double-blind, randomized clinical trial of the effect on postoperative pain
    Perioperativ installation af ropivacain ved mastektomi – med eller uden aksilrømning efter sentinel node diagnostik eller kendte lymfeknudemetastaser - En dobbeltblindet randomiseret klinisk undersøgelse af den postoperative smertestillende effekt
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Perioperativ installation of ropivacain in mastectomy – with or without axillary lymph node dissection after sentinel node diagnostics or known lymph node metastasis – A double-blind, randomized clinical trial of the effect on postoperative pain
    Perioperativ installation af ropivacain ved mastektomi – med eller uden aksilrømning efter sentinel node diagnostik eller kendte lymfeknudemetastaser - En dobbeltblindet randomiseret klinisk undersøgelse af den postoperative smertestillende effekt
    A.4.1Sponsor's protocol code number01
    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 SponsorSydvestjysk Sygehus, Esbjerg
    B.1.3.4CountryDenmark
    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 supportSydvestjysk Sygehus, Esbjerg
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSydvestjysk Sygehus, Esbjerg
    B.5.2Functional name of contact pointAfdelingen for Operation og Anæstes
    B.5.3 Address:
    B.5.3.1Street AddressFinsensgade 35
    B.5.3.2Town/ cityEsbjerg
    B.5.3.3Post code6700
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4579182645
    B.5.5Fax number+4579182655
    B.5.6E-mailsrunel@dadlnet.dk
    B.Sponsor: 2
    B.1.1Name of SponsorOdense Universitetshospital
    B.1.3.4CountryDenmark
    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 supportSydvestjysk Sygehus, Esbjerg
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense Universitetshospital
    B.5.2Functional name of contact pointSøren Rune Larsen
    B.5.3 Address:
    B.5.3.1Street AddressKløvervænget 20B, 7. sal
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4540603179
    B.5.6E-mailsrunel@dadlnet.dk
    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 Ropivacain, Fresenius Kabi ® Solution for infusion 2 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameRopivacain
    D.3.2Product code "Not Applicable"
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROPIVACAINE
    D.3.9.1CAS number 84057-95-4
    D.3.9.4EV Substance CodeSUB10382MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeamide-type local anesthetics
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unilateral mastectomy with or without axillary lymph node dissection
    Unilateral mastektomi med og uden aksilrømning
    E.1.1.1Medical condition in easily understood language
    Unilateral removal of the breast with or without removal of lymph nodes in the armpit
    Ensidig fjernelse af bryst med eller uden fjernelse af lymfeknuder i armhulen
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 investigate the effect on pain relief, after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation.
    The effect is rated via VAS-score (Visual Analogue Scale) an modified VAS-score
    At undersøge den smertelindrende effekt af ropivacain med adrenalin ved installation ved unilateral mastektomi med og uden aksilrømning givet ved operationens afslutning.
    Effekten vurderes postoperativt ved hjælp af VAS-score (Visuel Analog Skala) og modificeret VAS-score.
    E.2.2Secondary objectives of the trial
    Secondary to evaluate the effect on PONV (Postoperative nausea and vomiting), postoperative use of analgesia and antiemetic, length of hospital stay and time till first mobilisation.
    Sekundært vurderes om installationen har effekt på PONV (Postoperative nausea and vomiting), det postoperative forbrug af smerte- og kvalmestillende medicin, på indlæggelsestiden og på tiden til mobilisering.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Unilateral mastectomy with or without axillary lymph node dissection after sentinel lymph node biopsy or known lymph node metastases
    2. Woman
    3. Age > 18 years
    4. Capable of giving written informed consent
    5. ASA 1-2 (American Society of Anaesthesiologists physical status classification system)
    1. Unilateral mastektomi med eller uden aksilrømning efter sentinel node diagnostik eller kendte lymfeknudemetastaser.
    2. Kvinde.
    3. Alder > 18 år
    4. Myndig.
    5. ASA 1-2 (American Society of Anaesthesiologists klassifikationssystem af patientens almen tilstand)
    E.4Principal exclusion criteria
    1. Person not capable of using VAS
    2. Surgical complications demanding reoperation of the affected breast
    3. Any kind of former surgery to the affected breast
    4. Pregnancy
    5. Patient not capable of giving written informed consent
    6. Patient having other kind of breast surgery or axillary lymph node dissection
    7. Patient whit new onset of pain or deterioration to chronic pain during the last 24 hours
    8. Preoperative receiving treatment with medicine (prescript or non prescript) for new onset of pain or deterioration to chronic pain during the last 14 days. (Patients with well controlled chronic pain without deterioration may participate in the trial)
    9. Preoperative receiving treatment with medicine for nausea or vomiting during the last 14 days
    10. Patients receiving treatment with MAO-inhibiters or Tricyclic antidepressants during the last 3 months.
    11. Patient known to suffer from migraine
    12. Other kind of anaesthesia than the one described in the protocol
    13. Contraindication towards the investigational medicinal product
    1. Personer som ikke er i stand til at bruge VAS.
    2. Operationskomplikationer som kræver re-operation i samme bryst.
    3. Enhver form for tidliger operation i samme bryst.
    4. Graviditet.
    5. Pt. som ikke er i stand til at give samtykke.
    6. Pt. som får foretaget anden form for brystkirurgi eller aksilrømning.
    7. Pt. med nyopståede smerter eller forværring af kroniske smerter inden for det sidste døgn
    8. Præoperativt i behandling med medicin (håndkøbs såvel som receptpligtig) mod nyopståede smerte eller mod forværring af kroniske smerter de sidste 14 dage. (Patienter med velbehandlede kroniske smerter uden forværring kan deltage)
    9. Præoperativt i behandling med medicin mod kvalme eller opkast de sidste 14 dage.
    10. Patienter i behandling med MAO-hæmmere og/eller tricycliske antidepressiva de sidste 3 måneder.
    11. Pt. med kendt migræne
    12. Anden bedøvelse end den i protokollen under punkt 10.1.2 beskrevne.
    13. Kontraindikationer mod undersøgelsesmedicinen som beskrevet under 11.1.2.
    E.5 End points
    E.5.1Primary end point(s)
    Visuel analog score
    Visuel analog score
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 houres after installation of the IMP
    24 timer efter installation af undersøgelsesmedicinen
    E.5.2Secondary end point(s)
    Modified visuel analog score postoperativ
    Incidence of nausea
    Incidence of vomiting
    Use of analgetic
    Use of antiemetic
    Time of stay in the postanaesthesia care unit
    Time till end of hospital stay
    Time till first mobilisation
    Modificeret visuel analog score postoperativt.
    Forekomst af kvalme.
    Forekomst af opkast.
    Forbrug af analgetika.
    Forbrug af antiemetika.
    Tid på opvågningen.
    Tid til udskrivning.
    Tid til første mobilisering.
    Tid til mobilisering.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 houres after installation of the IMP
    24 timer efter installation af undersøgelsesmedicinen
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 Yes
    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
    24 hours after installation of the IMP in the last patient, unless there is an adverse event that needs follow up.
    24 timer efter installation af undersøgelsesmedicinen i den sidste patient, medmindre der er en hændelser eller bivirkninger som kræver yderligere opfølgning.
    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 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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-27. Yes
    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 state64
    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)
    Not different from the expected normal treatment
    Ikke anderledes end den vanlige behandling
    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 Decision2012-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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