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    Summary
    EudraCT Number:2009-017595-25
    Sponsor's Protocol Code Number:04-AnIt-09/UKM09_0031
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-01-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-017595-25
    A.3Full title of the trial
    Balanced 6 % HES 130/0.4 vs. balanced crystalloid-based infusion in patients undergoing colorectal surgery
    Balancierte 6% HES 130/0.4-Lösung vs. balancierte Kristalloid-Lösung bei Patienten mit kolorektalen Eingriffen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of cristalloid infusion (solution with electrolytes) vs colloid infusion (solution with hydroxyethylstarch) in patients with colorectal surgery
    Vergleich von Elektrolytlösung in körpereigener Zusammensetzung mit einer sog. Kolloidlösung (Infusion mit Stärkezusatz) bei Patienten mit Dickdarmoperationen
    A.3.2Name or abbreviated title of the trial where available
    KoKris
    A.4.1Sponsor's protocol code number04-AnIt-09/UKM09_0031
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01303250
    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 SponsorUniversity Hospital Muenster
    B.1.3.4CountryGermany
    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 supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Muenster
    B.5.2Functional name of contact pointDept. of Anaesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressAlbert-Schweitzer-Campus 1, A1
    B.5.3.2Town/ cityMuenster
    B.5.3.3Post codeD-48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+4925183-47267
    B.5.5Fax number64925183-48667
    B.5.6E-mailwempe-c@anit.uni-muenster.de
    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 Volulyte 6 % Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for 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.3.9.1CAS number 9005-27-0
    D.3.9.3Other descriptive nameHETASTARCH
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 6131904
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    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 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 Jonosteril
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for 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.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.430
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 6131904
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.674
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 127-08-2
    D.3.9.3Other descriptive namePOTASSIUM ACETATE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.393
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 16674-78-5
    D.3.9.3Other descriptive nameMAGNESIUM ACETATE TETRAHYDRATE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.268
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 62-54-4
    D.3.9.3Other descriptive nameCALCIUM ACETATE
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.261
    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
    Patients undergoing colorectal surgery
    Patienten mit elektiven kolorektalen Eingriffen
    E.1.1.1Medical condition in easily understood language
    Patients scheduled for colorectal surgery
    Patienten mit geplanten darmchirurgischen Eingriffen
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10040668
    E.1.2Term Sigmoid hemicolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009879
    E.1.2Term Colectomy total
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10059848
    E.1.2Term Proctocolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009877
    E.1.2Term Colectomy NOS
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019460
    E.1.2Term Hemicolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10039153
    E.1.2Term Right hemicolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024107
    E.1.2Term Left hemicolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063950
    E.1.2Term Ileocolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061778
    E.1.2Term Colectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10044083
    E.1.2Term Total colectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009878
    E.1.2Term Colectomy partial
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10063065
    E.1.2Term Anterior rectum resection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009880
    E.1.2Term Colectomy transverse
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10033684
    E.1.2Term Panproctocolectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10044447
    E.1.2Term Transverse colectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 two goal directed infusion therapies for patients undergoing open colorectal surgery with Volulyte (colloid treatment group) or Jonosteril (crystalloid control group). Comparison between the two groups will be based on the amount of fluids (mL) required to achieve hemodynamic stabilization.
    Das primäre Ziel ist zu untersuchen, ob die Art des Volumenersatzes einen Einfluss auf die intraoperativ notwendige Flüssigkeitsmenge zur Erreichen einer hämodynamischen Stabilität besitzt.
    E.2.2Secondary objectives of the trial
    - incidence of surgery related complications until 28 and 90 day after surgery
    - incidence of PONV
    - Time of first defacation and signs of first bowl movements
    - postoperative pain
    - stroke volume, stroke volume variability, cardiac output
    - postoperative weight gain
    - extracellular water and intracellular water
    - total volume of study medication
    - total volume of PRB
    - need for vasopressors
    - NT-proBNP and Arginin-Vasopressin plasma level
    - Lactate level
    - time patients ready for discharge (according to discharge criteria)
    - incidence of readmission within 28 and 90 days
    - safety
    - Auftreten OP-bedingter Komplikationen im 28- und 90 Tage Follow-up
    - Auftreten von PONV
    - Gastrointestinale Funktion
    - Evaluation der Schmerzen
    - Schlagvolumen, Schlagvolumenvariabilität, Cardiac Output
    - Postoperative Gewichtszunahme
    - ECW, ICW
    - Gesamtmenge der infundierten Studienmedikation
    - Gesamtmenge der transfundierten Blutprodukte
    - Gabe von Vasopressoren
    - Veränderungen der NT-proBNP- und Arginin-Vasopressin-Plasmaspiegel
    - Laktatspiegel
    - Zeitpunkt der möglichen Entlassung gemäß definierter Entlassungskriterien
    - Inzidenz postoperativer Krankenhaus-Wiederaufnahmen infolge von OP-Komplikationen
    - Sicherheit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients undergoing elective colorectal surgery with signed written informed consent
    - Age >= 18 years
    - Sinus rhythm
    - Patienten mit elektiver kolorektaler Operation
    - Alter > = 18 Jahre
    - Sinusrhythmus
    - Schriftliche Einverständniserklärung des Patienten
    E.4Principal exclusion criteria
    - patients younger than 18 years
    - women, who are pregnant or nursing
    - severe cardiamyopathy or severe heart failure
    - history of coagulation disorders
    - intracranial hemorrhage
    - patients with severe cardiovascular or respiratory disorders
    - renal insufficiency (creatinine > 2 mg/dL or creatinine clearance <=30mL/min)
    - severe liver diseases
    - atrial fibrillation or ventricular tachycardia
    - lung edema
    - hypertonic dehydration
    - known hypersensitivity to study medication
    - preoperative anemia with hemoglobin levels <= 10 mg/dL
    - Alter < 18 Jahre
    - Frauen während der Schwangerschaft und Stillzeit
    - Patienten mit schwerer Kardiomyopathie oder schwerem Herzversagen
    - Schwere Gerinnungsstörungen
    - Intrakranielle Blutungen
    - Patienten mit schwersten Erkrankungen des kardiovaskulären oder respiratorischen Systems
    - Niereninsuffizienz (Kreatinin-Cl <= 30ml/min oder Kreatinin > 2 mg/dl)
    - Schwere Lebererkrankungen
    - Vorbestehendes Vorhofflimmern sowie rezidivierende ventrikuläre Tachykardien
    - Lungenödem
    - Hypertone Dehydratation
    - Bekannte Überempfindlichkeit gegen die Studienmedikation
    - Präoperative Anämien mit einem Hb <= 10 mg/dl
    E.5 End points
    E.5.1Primary end point(s)
    Total volume of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized
    Intraoperative Flüssigkeitszufuhr, die zur hämodynamischen Stabilisierung notwendig ist
    E.5.1.1Timepoint(s) of evaluation of this end point
    intraoperatively
    intraoperativ
    E.5.2Secondary end point(s)
    - Incidence of surgery related complications
    - Incidence of nausea and vomiting
    - Gastrointestinal function
    - Postoperative pain
    - SVV, SV, CI
    - Postoperative weight gain
    - Total volume of study medication
    - ECW, ICW, TBW
    - Total volume of blood products
    - Administration of vasopressors
    - Postoperative changes in NT-proBNP and arginine vasopressin plasma levels
    - Hospitalization time
    - Incidence of readmissions
    - Safety
    - Auftreten OP-bedingter Komplikationen
    - Auftreten von PONV
    - Gastrointestinale Funktion
    - Evaluation der Schmerzen
    - SVV, SV, CI
    - Postoperative Gewichtszunahme
    - Gesamtmenge der infundierten Studienmedikation
    - ECW, ICW, TBW
    - Gesamtmenge der transfundierten Blutprodukte am OP-Tag
    - Gabe von Vasopressoren am OP-Tag
    - Veränderungen der NT-proBNP- und Arginin-Vasopressin-Plasmaspiegel
    - Zeitpunkt der möglichen Entlassung gem. definierter Entlassungskriterien
    - Inzidenz postoperativer krankenhaus-Wiederaufnahmen infolge von OP-Komplikationen
    - Sicherheit
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 2, 6, 24, 48 and 72 h postoperatively (Pain and PONV)
    - daily until day 4 postoperatively (weight gain, ECW, ICW, TBW, gastrointestinal function, complications)
    - 28 and 90 days postoperatively (complication, readmission)
    - 30 min before anesthesia, 30 min after skin incision and immediately at the end of surgery (SV, SVV, CI)
    - 1 day postoperatively (plasma level)
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    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 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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    End of trial is the last visit of the last subject undergoing the trial
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state170
    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)
    The treatment is not different from the expected normal treatment of that condition
    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 Decision2011-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-03-23
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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