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    Summary
    EudraCT Number:2016-001530-10
    Sponsor's Protocol Code Number:NoPac01
    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:2018-10-21
    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 number2016-001530-10
    A.3Full title of the trial
    A randomised controlled trial of topical intranasal tranexamic acid versus placebo to reduce the need for nasal packing in patients presenting to the Emergency Department with spontaneous epistaxis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The NoPac study: Investigating a new treatment to help control nose bleeds
    A.3.2Name or abbreviated title of the trial where available
    Novel use of TXA to reduce the need for nasal packing in epistaxis
    A.4.1Sponsor's protocol code numberNoPac01
    A.5.4Other Identifiers
    Name:EudraCTNumber:2016-001530-10
    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 SponsorRoyal Devon & Exeter NHS Foundation Trust
    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 RfPB Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPeninsula Clinical Trials Unit
    B.5.2Functional name of contact pointTrial Manager
    B.5.3 Address:
    B.5.3.1Street AddressN16 ITTC Building, Plymouth Science Park
    B.5.3.2Town/ cityPlymouth
    B.5.3.3Post codePL6 8BX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01752 315252
    B.5.6E-mailnopac@plymouth.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.2.1.1.1Trade name Tranexamic Acid
    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 nameTranexamic acid
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    Topical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTranexamic Acid
    D.3.9.1CAS number 1197-18-8
    D.3.9.3Other descriptive nametrans-4(Aminomethyl)cyclohexanecarboxylic Acid
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atraumatic epistaxis
    E.1.1.1Medical condition in easily understood language
    Spontaneous, serious, nosebleeds (nosebleeds that occur in the absence of trauma/injury and that fail to stop after first aid treatment).
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10015090
    E.1.2Term Epistaxis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main research question is: Does treatment with intranasal TXA, in addition to standard first aid measures and topical vasoconstrictor treatment, reduce the need for nasal packing in adult patients presenting to the Emergency Department with spontaneous nosebleeds?

    In lay language, the research question is: For patients attending the Emergency Department (Accident and Emergency) with a serious nosebleed, can tranexamic acid applied inside the bleeding nostril reduce the need for nasal packing (a large dressing filling the nostril)?
    E.2.2Secondary objectives of the trial
    • any further treatment for nosebleed during the ED attendance
    • hospital admission and subsequent length of stay, measured in days
    • blood transfusion during hospital attendance
    • number of repeat nosebleeds within one week of initial ED attendance
    • any thrombotic (blood clot) event requiring any hospital re-attendance within one week of initial ED attendance
    • any further hospital treatments required for nosebleeds during the one week follow-up period, including details of the type of hospital episode
    • adverse events occurring up to one week after trial treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential participants must satisfy the following criteria to be enrolled in the study:
    • Aged 18 or over
    • Presenting to the ED with spontaneous, atraumatic epistaxis, unresolved with simple first aid and standard initial therapy.
    E.4Principal exclusion criteria
    Potential participants meeting any of the following criteria will be excluded from study participation:
    • Clinical evidence of shock, as determined by the treating clinician, or requirement for resuscitation (including but not limited to systolic BP< 90 mmHg).
    • Known allergy to TXA
    • Lacking capacity
    • Unwilling to give consent
    • No telephone or unwilling to be contacted by telephone
    • Known paranasal, nasopharyngeal or nasal cavity malignancy
    • Pregnancy
    • Sent to ED for specialist ENT treatment
    • Already undergone pre-hospital nasal packing
    • Prior participation in the study (i.e. received allocated treatment)
    • Prisoners
    • Epistaxis caused by trauma (excluding simple nose picking)
    • Known haemophilia
    E.5 End points
    E.5.1Primary end point(s)
    Use of anterior nasal packing (of any type) for treatment of epistaxis at any time during the ED attendance.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Discharge from ED to home, or admission to hospital ward.
    E.5.2Secondary end point(s)
    • any further treatment for epistaxis during the index ED attendance
    • hospital admission and subsequent length of stay, measured in days
    • blood transfusion during hospital attendance
    • incidence of recurrent epistaxis following trial intervention and within 7 days of the index ED attendance
    • any thrombotic event requiring any hospital re-attendance within 7 days of the index ED attendance
    • any further hospital treatments required for epistaxis within 7 days of the index ED attendance, including details of the type of hospital episode
    • adverse events occurring within 7 days of the index ED attendance
    E.5.2.1Timepoint(s) of evaluation of this end point
    Discharge from the ED either to home or admitted for inpatient stay to a ward.

    The follow-up phone call will be made between 7-14 days after the index attendance to the ED. Efficacy and safety data will be collected for the 7 day period post index attendance at the ED.
    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) 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 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 concerned12
    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
    Completion of last participant's one week telephone follow-up.
    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 months5
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    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.1.1Number 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 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 state450
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 450
    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)
    The study is for topical application of TXA to treat an acute episode of epistaxis, so continued provision of the IMP is not relevant in this case. Tranexamic acid is widely available in generic format, and if the trial results confirm its effectiveness as a topical application in epistaxis, use of TXA could be incorporated into practice and/or departmental guidelines without delay.
    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 NIHR CRN-SW
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-22
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