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    Summary
    EudraCT Number:2013-003327-11
    Sponsor's Protocol Code Number:3623
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-003327-11
    A.3Full title of the trial
    Alternative Treatments of Adult female Urinary Tract Infection: a double blind, placebo controlled,factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ATAFUTI - A Trial Investigating Alternative Treatments of Adult Female Urinary Tract Infection.
    A.3.2Name or abbreviated title of the trial where available
    ATAFUTI
    A.4.1Sponsor's protocol code number3623
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN43397016
    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 Southampton
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR School for Primary Care Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouthampton, Clinical Trials Unit
    B.5.2Functional name of contact pointATAFUTI Trials Manager
    B.5.3 Address:
    B.5.3.1Street AddressMP 131, Southampton General Hospital, Tremona Road
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number023812035171
    B.5.5Fax number08447740621
    B.5.6E-mailcatherine.simpson@soton.ac.uk
    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 ARCTUVAN
    D.2.1.1.2Name of the Marketing Authorisation holderTemmler Werke 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.3.1Product nameUva ursi
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNArbutin
    D.3.9.1CAS number 497-76-7
    D.3.9.3Other descriptive namehydroquinone-β-D-monoglucopyranoside
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number76.13
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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 placeboCapsule
    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
    Acute urinary tract infections.
    E.1.1.1Medical condition in easily understood language
    Acute urinary tract infections
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000698
    E.1.2Term Acute cystitis
    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
    To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice provide relief from urinary symptoms in adult women with suspected UTI.
    E.2.2Secondary objectives of the trial
    To evaluate whether Uva ursi compared to placebo or the advice to take ibuprofen compared to no advice result in reduced antibiotic use in adult women with suspected UTI.

    To determine the patient/practitioner barriers to implementation of a delayed antibiotic prescription approach and the use of herbal medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult women (18-70) presenting to primary care with suspected lower urinary tract infection i.e. with at least one of dysuria, urgency or frequency.
    • Patient able to provide informed written consent.
    • Women willing to accept a delayed prescription for antibiotics.
    E.4Principal exclusion criteria
    • Known or suspected pregnancy or breast feeding
    In women of child bearing age a urine pregnancy test will usually be performed unless not indicated (for instance prior hysterectomy)
    • Known immunodeficiency state, long term corticosteroids therapy or chemotherapy
    • Diabetes
    • Has any of the following (A – F) known contra-indications or cautions to Ibuprofen and any as listed in the current SmPC:
    A. Asthmatics sensitive to NSAIDS/ Ibuprofen or Aspirin
    B. Severe heart failure and uncontrolled hypertension
    C. Active gastro-intestinal ulceration or bleeding
    D. Crohn’s disease or ulcerative colitis
    E. Documented poor renal function
    F. Chronic Kidney disease (Grade 3 - 5)
    • Currently or within 7 days taken antibiotics
    • Using a NSAID or Uva Ursi preparation and unwilling to discontinue for the study period
    • Suspected upper urinary tract infection (back pain, high fever>38C, systemic illness)
    • Women whom immediate antibiotics are otherwise indicated - frequent recurrent infection: >3 UTI episodes in past 12 months
    • Defect of the blood clotting system
    • Bladder surgery including cystoscopy in the last four weeks.
    • Currently taking Warfarin
    • Recruited to another interventional randomised control trial in previous 4 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Symptom severity at day 2-4 recorded in a validated self report diary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 2 -4.
    E.5.2Secondary end point(s)
    Use of antibiotics.
    Duration of moderately bad symptoms.
    Reconsultation in one and three months with UTI.
    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 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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    2 x 2 factorial design
    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 concerned60
    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
    Patients notes review will be completed 3 months after the last patient is randomised into the trial to assess how many return visits have been made to the GP with Urinary Tract Infections.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 376
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state376
    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)
    There is no planned continued provision of the intervention after the research has finished.
    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 CRN Wessex
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-21
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