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    Summary
    EudraCT Number:2013-001795-38
    Sponsor's Protocol Code Number:A206
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-09-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001795-38
    A.3Full title of the trial
    CRANIAL-FACIAL PAIN TREATMENT: PROSPECTIC, RANDOMIZED, OPEN-LABEL STUDY ON TRANSNASAL NONSURGICAL BLOCKADE VERSUS PHARMACOLOGICAL THERAPY
    IL TRATTAMENTO DEL DOLORE CRANIO FACCIALE: STUDIO PROSPETTICO, RANDOMIZZATO, IN APERTO SUL BLOCCO INCRUENTO TRANSNASALE VERSUS TRATTAMENTO FARMACOLOGICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CRANIAL-FACIAL PAIN TREATMENT: PROSPECTIC, RANDOMIZED, OPEN-LABEL STUDY ON TRANSNASAL NONSURGICAL BLOCKADE VERSUS PHARMACOLOGICAL THERAPY
    IL TRATTAMENTO DEL DOLORE CRANIO FACCIALE: STUDIO PROSPETTICO, RANDOMIZZATO, IN APERTO SUL BLOCCO INCRUENTO TRANSNASALE VERSUS TRATTAMENTO FARMACOLOGICO
    A.4.1Sponsor's protocol code numberA206
    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 SponsorAZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO
    B.1.3.4CountryItaly
    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 supportAzienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO
    B.5.2Functional name of contact pointEMERGENCY WARD
    B.5.3 Address:
    B.5.3.1Street AddressLARGO MEDAGLIE D'ORO
    B.5.3.2Town/ cityTRENTO
    B.5.3.3Post code38122
    B.5.3.4CountryItaly
    B.5.4Telephone number00390461903033
    B.5.5Fax number00390461903588
    B.5.6E-mailsimone.zanella@apss.tn.it
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEndosinusial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEPIVACAINE
    D.3.9.1CAS number 96-88-8
    D.3.9.4EV Substance CodeSUB14514MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 2
    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
    Cranial facial pain
    Dolore cranio facciale
    E.1.1.1Medical condition in easily understood language
    Cranial facial pain
    Dolore cranio facciale
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    To compare the efficacy in the short-term (1 hour after the treatments) between the intranasal sphenopalatin nonoperative ganglio blockade and standard pharmacological treatment recommended in the centre and pre-defined for the purposes of the requirements of the protocol for the therapy of facial cranial pain
    Confrontare l'efficacia a breve termine (1 ora dopo il trattamento) del blocco incruento tansnasale del ganglio sfeno-palatino e del trattamento farmacologico raccomandato nel centro e pre-definito ai fini dei requisiti del protocollo nella terapia del dolore cranio facciale
    E.2.2Secondary objectives of the trial
    To compare the efficacy at 30 minutes, 24-48 hours after the treatments between the intranasal sphenopalatin nonoperative ganglio blockade and standard pharmacological treatment recommended in the centre and pre-defined for the purposes of the requirements of the protocol for the therapy of facial cranial pain
    Indagare l'efficacia del blocco incruento sfeno-palatino per via transnasale a 30 minuti e dopo 24-48 ore dai trattamenti rispetto alla terapia farmacologica raccomandata nel centro e pre-definita ai fini delle esigenze del protocollo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who access the emergency room:
    1. Anterior cranio-facial pain that does not pass the median line of the face: periorbital primary headache, trigeminal neuralgia, acute sinusitis, toothache.
    2. Age> 18 years old
    3. Ability to provide informed consent
    Pazienti che accedono al pronto soccorso con
    1.Dolore anteriore cranio-facciale che non supera la linea mediana del volto (emivolto, emicranio): cefalea primaria periorbitaria, nevralgia del trigemino, sinusite acuta, odontalgia.
    2.Età > 18 anni
    3.Capacità di fornire consenso informato alla partecipazione al presente studio

    E.4Principal exclusion criteria
    1. Age <18 years
    2. known or suspected pregnancy
    3. Inability to provide informed consent
    4. Fever
    5. Suspicion or certainty of neurological disease as a cause of pain / symptoms
    6. Acute eye condition (glaucoma)
    7. Headache onset "thunderclap", patients with acquired immunodeficiency and concomitant new headache, headache arising during exercise or sexual activity, headache due to drug overuse, consumption of drugs or alcohol, chronic use of antidepressants, minor tranquilizers and more, patients followed by the Center for Mental Health, detainees and patients with proven or suspected pregnancy
    1. Età <18 anni
    2. Stato certo o presunto di gravidanza
    3. Incapacità a fornire consenso informato
    4. Febbre
    5. Sospetto o certezza di patologia neurologica come causa del dolore/sintomi
    6. Patologia oculare acuta (glaucoma)
    7. Cefalea ad esordio “a rombo di tuono”, pazienti con immunodeficit acquisito e concomitante cefalea di nuova insorgenza, cefalea insorta durante esercizio fisico od attività sessuale, cefalea da abuso di farmaci, consumo di droghe od alcol, uso cronico di antidepressivi, tranquillanti minori e maggiori, pazienti seguiti dal Centro di Salute Mentale, detenuti presso Case Circondariali e pazienti con gravidanza presunta od accertata.
    E.5 End points
    E.5.1Primary end point(s)
    Pain decrease of at least 75% according to the VAS score
    Si assume come significativo un decremento del dolore in almeno il 75% dei casi (proporzione di efficacia 0,75) così come misurato con scala VAS dopo un’ora dai trattamenti in entrambi i gruppi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 1 hour from the treatments
    Dopo un’ora dal trattamento in entrambi i gruppi.
    E.5.2Secondary end point(s)
    Pain decrease according to the VAS score
    McGill Questionnaire Pain
    Type and dosage of drugs assumed
    Le VAS misurate prima e successivamente (a 30 minuti e dopo 24-48 ore) sono considerate outcome secondari, come anche il Mc Gill Questionnaire Pain insieme alla quantità e tipologia di farmaci assunti
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 30 minutes and 24-48 hours form the treatment
    a 30 minuti e dopo 24-48 ore
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 162
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 162
    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 state162
    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
    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 Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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