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    Summary
    EudraCT Number:2012-005842-39
    Sponsor's Protocol Code Number:226361
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-05
    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 number2012-005842-39
    A.3Full title of the trial
    Treatment of eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study for evaluation of treatment effect on group level including symtom questionnaires
    Behandling av eosinofil esofagit med mometason furoat spray: En randomiserad, placebo-kontrollerad fas II studie för utvärdering av behandlingseffekt på gruppnivå med symtom-frågeformulär
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of patients with eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study
    Behandling av patienter med allergisk matstrupe med Nasonex spray: en randomiserad, placebo-kontrolleradfas II studie.
    A.4.1Sponsor's protocol code number226361
    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 SponsorNU-sjukvården, Norra Älvsborgs Länssjukhus
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMogens Bove
    B.5.2Functional name of contact pointMogens Bove
    B.5.3 Address:
    B.5.3.1Street AddressÖNH-kliniken NÄL
    B.5.3.2Town/ cityTrollhättan
    B.5.3.3Post code46185
    B.5.3.4CountrySweden
    B.5.6E-mailmogens.bove@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 Nasonex
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    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 Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension and solution for spray
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Eosinphilic Esophagitis
    Eosinofil esofagit
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Eosphagitis
    Allergisk matstrupe
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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
    Evaluate the effect of local steroid treatment with Nasonex on swallowing difficulties in patients with eosinophilic esophagitis
    Utvärdera effekten av lokal steroidbehandling med Nasonex på sväljningsbesvär (huvudsymtomet) hos patienter med allergisk matstrupe.
    E.2.2Secondary objectives of the trial
    Evaluate patients quality of life and any side-effects
    Utvärdera patienternas livskvalitet samt eventuell förekomst av bieffekter
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >18 years
    - New diagnosed eosinophilic esophagitis according to special criteria
    - Women in fertile age if pregnancy is not planned and contraceptive is used during the treatment period, 8 weeks
    - Verbal and written informed consent
    - Ålder minst 18 år
    - Nydiagnostiserade fall med uppfyllda diagnoskriterier för EoE d.v.s. minst 15 eosinofila celler per högförstoringsfält (Förstoring 10 ggr 40=400ggr) i något synfält i någon biopsi* i esofagus och samtidiga symtom på esofageal dysfunktion främst dysfagi.
    -Kvinnor i fertil ålder kan deltaga under förutsättning att graviditet inte planeras samt att antikonceptionsmedel används under behandlingstiden.
    - Deltagande förutsätter muntligt och skriftligt informerat och signerat samtyckesformulär (se patientinformation och samtyckesformulär).
    E.4Principal exclusion criteria
    - Local infection in pharynx or esophagus
    - Active or latent tuberculosis in air-route
    - Recent trauma or extensive surgery
    - Recent extensive infection or other physical stress
    - Sign of or suspected dehydration
    - Earlier injury, disease or operation on adrenal gland or hypophysis
    - earlier or clinical signs of adrenal gland insufficience
    - Pharynx- or esophagus surgery or other trauma in esophagus which is not healed
    - Planned elective surgery during treatment period
    - Pregnancy, ongoing or planned
    - Woman in fertile age not using contraceptive during treatment period
    - Glaucoma
    - Hypersensitivity to any of the ingredients
    - General or local steroid treatment during the last 4 months
    - Contra indication to steroid treatment (immune-deficiensy or -suppression, gastric ulcer, diabetes
    - Medication affecting the mobility of the oesophagus during the treatment period
    - Protone pump inhibitor treatment during or up to 2 weeks before treatment period
    - Ulcus ventriculi or duodeni where healing is not verified with endoscopy
    - Other reason for dysphagia ( cancer, connective tissue disorder, neurological disorder)
    - Not able to give consent or completing questionnaires
    - Lokal infektion i pharynx- eller esofagus såsom svamp- bakterie- eller virusinfektion
    - Aktiv eller latent tuberkulos i luftvägar
    - Nyligen genomgången betydande trauma eller större kirurgiskt ingrepp
    - Nyligen haft betydande infektion eller annan fysisk stress
    - Tecken på eller misstanke om dehydrering
    - Anamnes på skada, sjukdom eller operation i binjurar eller hypofys
    - Anamnes på eller kliniska tecken på binjurebarkinsufficiens
    - Pharynx- eller esofaguskirurgi eller annat trauma i esofagus (inkl. främmande kropp med vasst föremål) där läkning inte har skett. Vid anamnes talande för detta skall utläkning vara säkerställd med esofago-gastroskopi.
    - Planerad elektiv kirurgi under behandlingstiden
    - Graviditet, pågående eller planerad
    -Kvinna i fertil ålder som inte använder preventivmedel under studieperioden
    - Glaucom
    - Överkänslighet mot någon av beståndsdelarna
    - Systemisk eller lokal steroidbehandling senaste 4 månader
    - Kontraindikation för steroidbehandling (immun-brist eller suppression, magsår, diabetes)
    - Medicinering som påverkar matstrupens motilitet (cisaprid, erythromycin) under behandlingsperioden.
    - Protonpumhämmare under eller upp till 2 veckor innan behandlingsperioden
    - Ulcus ventriculi eller –duodeni där utläkning inte är bekräftat endoskopiskt
    - Annan orsak till dysfagi (cancer, bindvävssjukdom, neurologisk sjukdom)
    - Försöksperson som inte själv kan samtycka till studien eller fylla i frågeformul
    E.5 End points
    E.5.1Primary end point(s)
    Difference in dysphagia total score on Watson Dysphagia Scale (WDS) between value after treatment and at treatment start
    Som mått på behandlingseffekt på huvudsymtomet dysfagi används skillnad i total score från Watson Dysphagia Scale (WDS) mellan värden efter behandling och före behandling (utgångsvärdet)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 8 weeks treatment
    Efter 8 veckors behandling
    E.5.2Secondary end point(s)
    - Evaluation of EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item
    - Evaluation of dysphagia secondary concequences of well being measured in "global health and social functioning dimensions" in SF-36
    - Utvärdering av EORTC QLQ-OES18 dysphagia scale, the eating scale and choking item
    - Utvärdering av dysfagins sekundära konsekvenser för välbefinnandet används MV för "global health and social functioning dimensions" ur SF-36
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 8 weeks treatment
    Efter 8 veckors behandling
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    LVLS
    Sista besök sista patient
    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 months2
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state60
    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)
    After last visit the patient will receive normal common care. No extra visit is planned but the patient is asked to make contact diect to the investigator if needed.
    Efter avslutande besök gäller sedvanlig sjukvård. Patienten uppmanas att höra av sig vid behov direkt till respektive prövare.
    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 Decision2013-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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