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    Summary
    EudraCT Number:2012-002776-14
    Sponsor's Protocol Code Number:97
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-06
    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 ConcernedNorway - NOMA
    A.2EudraCT number2012-002776-14
    A.3Full title of the trial
    Ibuprofen versus mecillinam for uncomplicated cystitis in adult, non-pregnant women
    Ibuprofen versus mecillinam i behandlingen av ukomplisert cyctitt hos voksne, ikke-gravide kvinner
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of cystitis in adult, non-pregnant women
    Behandling av blærekatarr hos voksne, ikke-gravide kvinner
    A.4.1Sponsor's protocol code number97
    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 of Oslo, Faculty of medicine, Institute of Health and Society
    B.1.3.4CountryNorway
    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 supportThe Norwegian Research Council
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportThe National Centre of Emergency Primary Health Care
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oslo
    B.5.2Functional name of contact pointIngvild Vik
    B.5.3 Address:
    B.5.3.1Street AddressAntibiotic Center of Primary Care
    B.5.3.2Town/ cityP.o. box 1130, Blindern, Oslo
    B.5.3.3Post code0318
    B.5.3.4CountryNorway
    B.5.4Telephone number004723487000
    B.5.6E-mailingvild.vik@medisin.uio.no
    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 Ibuprofen ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral 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.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 Selexid
    D.2.1.1.2Name of the Marketing Authorisation holderLeo Pharma
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uncomplicated cystitis in adult, non pregnant women, age 18-60.
    Ukomplisert cystitt hos voksne, ikke-gravide kvinner, alder 18-60.
    E.1.1.1Medical condition in easily understood language
    Cystitis in women
    Blærekatarr hos kvinner
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000699
    E.1.2Term Acute cystitis (excl in pregnancy)
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days.
    The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women.
    Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficiant as treatment with mecillinam in this group.
    Selv om ukomplisert cystitt er ansett å være en mild og for det meste selvbegrensende tilstand, vil de fleste pasienter som oppsøker lege på grunn av dette bli behandlet med antibiotika. Antibiotika vil gi en rask symptomlindring samt forkorte sykdomsforløpet. Formålet med denne studien er å evaluere ibuprofen versus mecillinam i behandlingen av ukomplisert cystitt hos voksne, ikke-gravide kvinner. Vi ønsker å se om ibuprofen vil være et likeverdig behandlingsalternativ til mecillinam i denne gruppen.
    E.2.2Secondary objectives of the trial
    Will it take longer for the patients in the ibuprofen group to feel well? Are there more complications in the ibuprofen group compared to the mecillinam group? Are they more likely to develop an upper urinary tract infection? Are they more likely to develop a second uncomplicated cystitis within the four weeks of follow up? Are there more positive urine cultures in the ibuprofen group after two weeks?
    Vil det ta lengre tid før pasientene i ibuoprofengruppen føler seg friske? Er det mer komplikasjoner i ibuprofengruppen sammenlignet med mecillinamgruppen? Har disse pasienten økt risiko for å utvikle en øvre urinveisinfeksjon? Har de økt risiko for å utvikle en ny ukomplisert cystitt i løpet av oppfølgingsperioden på fire uker? Er det flere positive urinkulturer i ibuprofengruppen etter to uker?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Woman between 18 and 60 years of age.
    Dysuria and urinary frequency and/or urinary urgency.
    Ability to speak, understand and write Norwegian/Swedish/Danish and ability to give consent.
    Kvinne mellom 18 og 60 år.
    Smerter/svie ved vannlating og hyppig vannlating eller økt trang til å late vannet.
    Snakker, forstår og skriver godt norsk/svensk/dansk og samtykkekompetent
    E.4Principal exclusion criteria
    Pregnancy/breastfeeding child under one month of age
    Diabetes
    Kidney disease or use of the drug probenecid
    Clinical suspicion of pyelonefritis; fever, reduced general condition, upper back pain
    Vaginal symptoms such as discharge or irritation
    Severe abdominal pain
    Symptoms that have lasted for more than seven days
    One or more urinary tract infections within the lasts four weeks
    Permanent bladder catheter or use of bladder catheter within the last four weeks
    Use of antibiotics within the last two weeks
    Previous allergic reaction to penicillin
    Previous allergic reaction to ibuprofen, or worsening of asthma when taking NSAIDs
    Narrow oesophagus
    Severe gastritis or previous ulcer
    Anticoagulative treatment
    Ongoing use of steroids
    Use of immunosuppressant drugs
    Thrombocytopenia
    Heart insufficiency
    Severe psychiatric illness or dementia
    Severe drug addiction
    Unable to communicate in Norwegian, Swedish or Danish language
    Gravid/ammer barn under 1 måned
    Sukkersyke
    Nyresykdom eller bruk av mdeisinen probenecid
    Symptomer på nyrebekkenbetennelse; feber, redusert almenntilstand, smerter øvre del rygg/mage
    Mye utflod, kløe og irritasjon i underlivet eller sterke smerter i magen
    Plager som har vedvart i over syv dager
    Urinveisinfeksjon (øvre/nedre) eller brukt urinveiskateter de siste fire uker
    Bruk av antibiotika i løpet av de siste to uker
    Tidligere allergisk reaksjon på penicillin
    Tidligere allergisk reaksjon eller astmaforverring ved bruk av ibuprofen
    Trangt spiserør
    Antikoagulasjonsbehandling
    Trombocytopeni
    Alvorlig gastritt eller tidligere magesår
    Pågående bruk av steroider
    Immunsuppressiv behandling
    Hjertesvikt
    Demens, alvorlig psykiatrisk lidelse eller alvorlig rusmisbruk
    Manglende evne til å kommunisere muntlig og skriftlig på norsk/svensk/dansk
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who feel cured by day four as registered in the patient diary
    Andel pasienter som føler seg friske innen fire dager, som registrert i pasientdagbok.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Four days
    Fire dager
    E.5.2Secondary end point(s)
    The patients’ symptom load with regard to specific symptoms.
    Proportion of patients who had a relapse of symptoms of uncomplicated cystitis within the study period.
    Proportion of patients who were in need of a secondary medical consult within the study period.
    Proportion of patients who developed an upper urinary tract infection (pyelonefritis).
    Proportion of patients who experienced severe adverse effects.
    Proportion of patients with a positive urine culture after two weeks.
    Pasientenes symptomstyrke med hensyn til spesifikke sympotmer.
    Andel pasienter som opplevde residiv av symptomer på ukomplisert cystitt i løpet av studieperioden.
    Andel pasienter som hadde behov for en ny legekonsultasjon i løpet av studieperioden.
    Andel pasienter som utviklet en øvre urinveisinfeksjon (pyelonefritt).
    Andel pasienter som opplevde alvorlige bivirkninger.
    Andel pasienter med positiv urinkultur etter to uker.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Four weeks
    Fire uker
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    We will end the trial when a sufficient number of patients have been included according to the power calculation, i.e. 400 patients in total, 200 in Oslo and 70 at each of the other three study sites. End of trial is four weeks after the visit of the last subject undergoing the trial since the follow up of the subject is four weeks after inclusion in the trial.
    Vi avslutter studien når vi har inkludert et tilfredsstillende antall pasienter i følge styrkeberegning, dvs 400 pasienter, 200 pasienter i Oslo og ca 70 ved hvert av de andre studiestedene. Vi avslutter datainnsamlingen fire uker etter at siste pasient er inkludert, dette er på grunn av at siste kontakt med pasientene er fire uker etter de ble inkludert.
    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 years1
    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: 400
    F.1.3Elderly (>=65 years) No
    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 2012-11-06. 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 state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 400
    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
    Ingen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation EMA Oslo
    G.4.3.4Network Country Norway
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation EMA Bergen
    G.4.3.4Network Country Norway
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation University of Copenhagen, Dept of General Practice
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation University of Lund, Dept of General Practice
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-07
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