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    Summary
    EudraCT Number:2013-004657-24
    Sponsor's Protocol Code Number:7985
    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:2014-09-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-004657-24
    A.3Full title of the trial
    A randomised, double-blind, placebo controlled, feasibility study exploring the role of Chinese herbal medicine in the treatment of women with recurrent urinary tract infections.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chinese herbal medicine for recurrent urinary tract infections
    A.3.2Name or abbreviated title of the trial where available
    CHM for RUTIs
    A.4.1Sponsor's protocol code number7985
    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 SponsorSouthampton University
    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
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouthampton University
    B.5.2Functional name of contact pointBarbara Halliday
    B.5.3 Address:
    B.5.3.1Street AddressBuilding 37 Room 4079 University Road Highfield
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO17 1BJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402380595058
    B.5.6E-mailB.Halliday@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 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 namePreventative Herbal Formula
    D.3.2Product code RUTI-p
    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 INNAstragalus membranaceus Moench
    D.3.9.2Current sponsor codePH1
    D.3.9.3Other descriptive nameHuang Qi
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSophora flavescens Aiton
    D.3.9.2Current sponsor codePH2
    D.3.9.3Other descriptive nameKu Shen
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLindera aggregata var. aggregate
    D.3.9.2Current sponsor codePH3
    D.3.9.3Other descriptive nameWu Yao
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) Yes
    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.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 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 nameAcute Herbal Formula
    D.3.2Product code RUTI-a
    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 INNOldenlandia diffusa (Willd.) Roxb.
    D.3.9.2Current sponsor codeAH1
    D.3.9.3Other descriptive nameBai Hua She She Cao
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCortex Phellodendron Amurense
    D.3.9.2Current sponsor codeAH2
    D.3.9.3Other descriptive nameHuang Bai
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLysimachia christinae Hance
    D.3.9.2Current sponsor codeAH3
    D.3.9.3Other descriptive nameJin Qian Cao
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Yes
    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
    Recurrent urinary tract infections
    E.1.1.1Medical condition in easily understood language
    Infections affecting the bladder that occur at least three times in 12 months.
    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 17.0
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    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 compare outcomes observed during and after the 16-week trial from participants in each of the 4 arms of the trial. In particular the:

    • duration and severity of acute urinary tract infections
    • rates of re-infection within the 4 month treatment period
    • quality of life measured by a validated questionnaire (MYMOP) and in depth
    qualitative research
    • rates of acute and prophylactic antibiotic use
    • adverse effects experienced during treatment
    • To assess the safety of CHM
    • long term changes (6 months after stopping the trial) from each intervention
    E.2.2Secondary objectives of the trial
    • To explore the feasibility of developing, implementing and evaluating a CHM intervention within the primary care networks with particular regard to recruitment, referral patterns, patient compliance, the use of a plausible herbal placebo, and drop out rates.

    • To evaluate the acceptability and sensitivity to change of different outcomes measures and to provide a provisional estimation of any effect size relating to CHM treatment that could inform a more definitive future study.

    • To use nested qualitative research and quantitative quality of life outcome measures to explore the experience of women taking CHM and to investigate any perceived differences between the delivery of standardised remedies via GPs and individualised remedies via CHM practitioners.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women will be eligible for the trial if they are aged over 18 and under 65 years of age and have reported 3 or more uncomplicated recurrent lower UTIs in the previous 12 months where at least one episode has been documented as bacterial UTI.

    The reason for the upper age limit of 65 years is that Chinese medicine differentiates several different diagnostic patterns relating to RUTIs. The herbal formulae used for this trial have been designed for a pattern more common in women aged under 65 years. Women over the age of 65 will tend to present with a different pattern to a younger age group and therefore the standardised formula may not be appropriate for them.
    E.4Principal exclusion criteria
    Women will be excluded from the trial if they have symptoms of complicated UTI’s such as acute pyelonephritis; have known hepatic or renal disease; are pregnant or breast feeding; have diabetes; have commenced a new treatment for RUTIs in the previous 6 months; are taking drugs which may interact with Chinese herbal medicine: cardiac glycosides (Digoxin), warfarin and lithium; have psychosis, dementia or terminal illness that may prevent completion of symptom diaries. During the trial women will be excluded if they develop significantly raised liver (ALT > 90 U/l) or renal function tests (GFR < 90 mL/mm/1.73m2). Any women who also become pregnant during the trial will also be advised to stop taking the CHM and to inform a member of the study team for further advice. If pregnancy is confirmed, the participant will be asked to withdraw from the intervention in the study and asked for their consent to remain for safety monitoring purposes.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcomes will be the number episodes of recurrent UTIs during the trial period and after 6 months follow up and the number of days of symptoms rated moderately bad or worse based on patient diaries.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All participants will receive treatment lasting 16 weeks. Subsequent to this there will be a 6 month follow up period to assess any lasting benefits from the intervention.
    E.5.2Secondary end point(s)
    After 6 months treatment we will be evaluating:

    • Symptom diaries indicating the severity of acute and recurrent UTI symptoms (reporting dysuria, haematuria, frequency during day and night, “smelly urine,” “tummy pain,” generally feeling unwell, and restriction of daily activities). Use of these diaries in this format for acute respiratory infections has been validated and shown to be sensitive to change (Watson et al 2001) and now have been shown to be sensitive to change, reliable, and having construct validity in UTIs (Little et al 2010a,b).

    • Rate of UTI recurrence-as reported in the symptom diaries completed for each acute UTI episode during the active phase of the trial.

    • In addition to the diary for acute UTIs participants will be asked to complete a monthly end of month diary in which they record number of days with symptoms, time lost from work etc. These diaries would provide information on the rate and severity of acute infection but also on the impact of low grade, chronic infection on the lives of women. Participants will be asked to complete both an acute and a monthly diary for the 6 month follow up of the trial to enable the evaluation of any longer term changes in infection rates.

    • Use of antibiotics for acute UTIs-elicited from symptom diaries and cross-referenced with GP notes.

    • The Borkevic and Devilly questionnaire will be used to assess participants’ attitudes relating to the effectiveness of CHM prior to and on completion of the trial (Devilly & Borkevic 2000).

    • MYMOP a validated patient centred QoL outcome completed every 4 weeks (Patterson 1996)

    • Economic assessment (EQ5D) to be completed prior to and on completion of the trial (also reduction in GP appointments gathered from a review of GP patient notes/ days lost to work). We will also estimate the quality of life during acute UTI episodes by the EQ5D and Euroqol thermometer at the beginning and end of each episode. The EQ5D cannot feasibly be used on a daily basis to estimate the quality of life profile during the episode, but the Euroqol thermometer can be used for this - as we are currently doing in the group’s studies in respiratory infections (the NIHR PRIME Programme)

    • Liver (ALT) and renal function tests (serum creatinine used to calculate GFR by using a conversion algorithm) conducted at weeks 0, 4 & 16.

    After 6 months there will be a phase of qualitative research:

    On completion of the trial semi-structured phenomenological interviews with 6-12 participants per group will be conducted to provide an in depth exploration of their experience of taking CHM and conventional care during the trial. We will also investigate the enablers and barriers that the affected the decision of women to participate in the trial. Purposive sampling will be used to include women taking standardised and individualised herbs during the trial. Once again the study will proceed iteratively and analysis will begin before completing all the interviews to allow emerging insights to inform subsequent interviews.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Symptom diaries will be completed if symptoms of UTIs occur. Antibiotic use will be assessed at 16 weeks and then again at the end of the 6 month follow up.

    Monthly diaries will be completed monthly.

    The Devilly and Borkevic questionnaire will be completed prior to the trial.

    MYMOP will be completed prior to the trial and thereafter on a monthly basis.

    Economic assessment (EQ5D) to be completed prior to and on completion of the trial

    Liver and Renal function tests will be conducted at weeks 0, 4 and 16.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 trial4
    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 concerned10
    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
    The trial will involve a 6 month follow up after the LVLS.Completion of this will be considered as the end of the trial.
    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 days2
    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 days2
    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: 80
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state80
    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)
    All participants will be able to access Chinese herbal medicine (CHM) from a qualified practitioner. Unfortunately, at present, this is only available outside the NHS.

    If this trial shows that the standardised (CHM) remedies have a therapeutic effect then further trials may be conducted and these remedies may be available within the NHS (as a special) or as an over the counter remedy.
    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 N/A
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Hampshire PCRN
    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 Decision2014-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-05
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