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    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-021502-38
    Sponsor's Protocol Code Number:LO-10-02
    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:2010-11-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-021502-38
    A.3Full title of the trial
    STUDIE ZUR MESSUNG DER VAGINALEN INTERLEUKINE BEI PATIENTINNEN MIT ZERVIKALEN NEOPLASIEN (CIN 1-3) ODER CHRONISCHER CANDIDIASIS VAGINALIS UNTER BEHANDLUNG MIT 4PHENYL-BUTYRATE
    A.4.1Sponsor's protocol code numberLO-10-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChristine Fromer Stiftung
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 name4 Phenyl-butyrate
    D.3.2Product code LU901
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN4 Phenyl-butyrate
    D.3.9.2Current sponsor codeLU901
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patienten mit diagnostizierter cervikaler Neoplasie (CIN1-3) oder chronisch - rezidivierender Vaginalcandidiasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.0
    E.1.2Level LLT
    E.1.2Classification code 10008290
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.0
    E.1.2Level LLT
    E.1.2Classification code 10046898
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Messung der vaginalen Interleukine.
    E.2.2Secondary objectives of the trial
    Beurteilung der CIN Regression unter Behandlung mit 4-PB bzw.
    Placebo.
    Beurteilung der chronisch rezidivierenden vaginalen Candidiasis
    unter Behandlung mit 4-PB bzw Placebo.
    Beurteilung der Sicherheit und Verträglichkeit der
    Studienmedikation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patientinnen mit histologisch/zytologisch bestätigter zervikaler
    intraepithelialer Neoplasie (CIN) Grad 1 oder höher.
    oder
    Patientinnen mit chronischer, rezidivierender Vaginalcandidiasis: -mit
    mindestens 4 Infektionsepisoden im lezten Jahr und mikrobiologisch
    bestätigter Candidainfektion bei Einschluss in der Studie.
    Die Patientin muss mindestens 18 Jahre alt sein.
    Sofern die Patientin oder Ihr Partner nicht sterilisiert sind, muss die Patientin während der Studie und 6 Wochen danach eine hocheffektive (Pearl-Index<1) Methode der Antikonzeption anwenden. Erlaubte hocheffektive Methoden sind: hormonelle antikontrazeptiva, hormonbeschichtete Vaginalring oder Spirale.
    Die Patientinnen müssen über die Studie informiert werden und
    müssen vor Behandlungsbeginn schriftlich einwilligen, an dieser
    Studie teilzunehmen.
    E.4Principal exclusion criteria
    Patientinnen, die bereits an einer anderen Studie teilnehmen, oder
    innert 30 Tage vor Start dieser Studie an einer anderen Studie
    teilgenommen haben.
    Patientinnen mit Immunschwächen (z.B. Aids, oder Behandlung mit
    Immunsupprimierenden Medikamente).
    Schwangerschaft (Auszuschliessen mittels Schwangersachftstest bei Studienbeginn) oder Stillzeit.
    Überempfindlichkeit gegenüber dem Prüfpräparat.
    Patientinnen mit Herzinsuffizienz, Leber- und Niereninsuffizienz sowie bei bestehender Natriumretention und Ödembildung.
    Jeder medizinischer Zustand, welcher die Fähigkeit Arzneimittel oral
    einzunehmen, einschränkt.
    Schwere systemische oder psychische Erkrankungen, die unvereinbar
    mit einer gleichzeitigen Studienteilnahme sind (nach Ermessen des
    Prüfartztes).
    Eine aktive Krebskrankheit (außer adäquat behandeltes
    Basalzellkarzinom der Haut) innert weniger als einem Jahr vor Beginn
    dieser Studie.
    E.5 End points
    E.5.1Primary end point(s)
    Beobachtung der vaginalen Interleukinen während der Studie.
    Sekundäre Endpunkte:
    Beurteilung der CIN Regression unter Behandlung mit 4-PB vs. Placebo
    Beurteilung der Vaginalcandidiasis unter Behandlung mit 4-PB vs.
    Placebo
    Beurteilung der Sicherheit und Verträglichkeit der Studienmedikation.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 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 Information not present in EudraCT
    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
    last visit of last subject
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 2010-11-11. 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 state120
    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 Decision2011-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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