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    Summary
    EudraCT Number:2013-001271-20
    Sponsor's Protocol Code Number:MOLT-2013-02
    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:2013-06-14
    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 number2013-001271-20
    A.3Full title of the trial
    A multicenter randomized open trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in reducing incidental predictable breakthrough pain (IP-BTP) at swallowing in patients with head and neck cancer undergoing radiotherapy
    Studio multicentrico, randomizzato in aperto che ha l’obiettivo di valutare l’efficacia del Fentanyl Pectin Spray Nasale (FPNS) rispetto ai trattamenti utilizzati nella normale pratica clinica, nel ridurre il dolore episodico intenso prevedibile associato alla deglutizione nei pazienti con tumore testa e collo in trattamento con radioterapia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter randomized open trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in reducing uncontrolled pain at swallowing (moderate/severe intensity) in patients with head and neck cancer undergoing radiotherapy.
    Studio multicentrico, randomizzato in aperto che ha l’obiettivo di valutare l’efficacia del Fentanyl Pectin Spray Nasale (FPNS) rispetto ai trattamenti utilizzati nella normale pratica clinica, nel ridurre il dolore episodico intenso prevedibile associato alla deglutizione nei pazienti con tumore testa e collo in trattamento con radioterapia
    A.3.2Name or abbreviated title of the trial where available
    PE.R.F.E.C.T. F.A.S.T STUDY PEctin Rapid Fentanil Efficacy Clinical Trial For pAin at Swallowing und
    A.4.1Sponsor's protocol code numberMOLT-2013-02
    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 SponsorL. Molteni & C dei F.lli Alitti Società di Esercizio S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportL. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationL. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressStrada Statale 67 – Loc. Granatieri
    B.5.3.2Town/ cityScandicci
    B.5.3.3Post code50018
    B.5.3.4CountryItaly
    B.5.6E-maili.corti@moltenifarma.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.2.1.1.1Trade name Pecfent nasal spray
    D.2.1.1.2Name of the Marketing Authorisation holderArchimeds Development Ltd
    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.3.1Product namePecFent 100mcg
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal 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 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 Pecfent nasal spray
    D.2.1.1.2Name of the Marketing Authorisation holderArchimeds Development Ltd
    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.3.1Product namePecFent 400mcg
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal 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
    Patients with head and neck cancer undergoing radiotherapy with uncontrolled pain at swallowing (moderate/severe intensity).
    Dolore alla deglutizione nei pazienti con tumore testa-collo in trattamento con radioterapia e/o chemioterapia.
    E.1.1.1Medical condition in easily understood language
    Patients with head and neck cancer undergoing radiotherapy with uncontrolled pain at swallowing
    i pazienti in studio, sono sottoposti a radioterapia e/o chemioterapia e hanno sviluppato dolore alla deglutizione
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10042648
    E.1.2Term Swallowing painful
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of Fentanyl pectin nasal spray (FPNS) compared with Physician Choice-Usual Care (PC-UC) in the management of swallowing IP-BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.
    Valutare l’efficacia del Fentanyl spray nasale (FPNS), rispetto al trattamento utilizzato dal medico nella normale pratica clinica (PC-UC), nella gestione del dolore alla deglutizione (IP-BTP) nei pazienti con tumore testa-collo sottoposti a radioterapia con o senza chemioterapia.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the evaluation of the effect of FPNS versus PC-UC in respect to:
    • time to reach the maximal pain reduction after administration of FPNS/PC-UC (evaluation of reduction in pain intensity score at each time point: 10,20,30 min after assuming FPNS or PC-UC )
    • clinically meaningful pain reduction
    • patient’s pain relief
    • administration of rescue medication
    • patient’s dysphagia
    • safety and tolerability
    Confrontare le due strategie di trattamento (FPNS vs PC-UC) rispetto a:
    • tempo dalla somministrazione del farmaco necessario per avere la massima riduzione dell’intensità del dolore
    • sollievo, clinicamente rilevante, dal dolore
    • sollievo dal dolore riferito dal paziente
    • utilizzo di una “terapia di salvataggio” (rescue medication)
    • disfagia
    • profilo di sicurezza e tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female aged 18 years or over
    2. Diagnosis of stage III-IV cancer of oral cavity, oropharynx, hypopharynx, larynx, salivary gland cancer
    3. Receiving radiation therapy (RT) with or without concurrent platinum based chemotherapy or cetuximab as first line treatment or as postoperative adjuvant treatment
    4. Background pain managed with a stable fixed dose of opioid equivalent to 60mg oral morphine daily
    5. Uncontrolled pain (IP-BTP) during swallowing with an intensity ≥4 on an 11-point numeric scale (0=no pain; 10=worst possible pain). This pain will have to be measured with the ingestion of a solid/liquid food (depending on the ability to swallow or less solid foods of the patient at moment)
    6. Patients able to receive a nasal spray therapy
    7. Willing and able to sign an informed consent form
    8. Females with childbearing potential must provide a negative pregnancy test and both males and females must be using adequate contraception during the study
    • Maschi e femmine con più di 18 anni
    • Diagnosi di cancro (stadio III-IV) del cavo orale, orofaringe, ipofaringe, laringe, cancro alle ghiandole salivari.
    • Trattamento con radioterapia con o senza concomitante chemioterapia con platino o cetuximab come prima linea di trattamento o come trattamento adiuvante post-operatorio.
    • Pazienti in grado di ricevere una terapia con spray nasale
    • Pazienti in grado di comprendere e firmare il consenso informato alla partecipazione allo studio.
    • Donne in età fertile con test di gravidanza negativo; i pazienti (uomini e donne) inclusi nello studio devono usare un adeguato metodo contraccettivo durante lo studio
    • Pazienti con dolore di base controllato con una dose di oppiodi equivalente a 60 mg di morfina orale al giorno
    • Pazienti con dolore non controllato alla deglutizione di intesità ≥4 punti misurato con una scala NRS 0-10 (0= nessun dolore alla deglutizione; 10 = il peggior dolore alla deglutizione).
    E.4Principal exclusion criteria
    1. Patients with known metastatic disease.
    2. Known hypersensitivity to opioids, to Fentanyl or to drugs used in the PC-UC, and/or to study medications’ formulation ingredients.
    3. Patients with impaired chemistry laboratory exams, assessed as routine clinical practice before radiotherapy start:
    a. Hepatic function:
    i. Total bilirubin > 2 times the upper-normal limit (ULN)
    ii. Serum transaminase > 5 times ULN
    b. Renal function:
    i. Serum creatinine concentration > 2 times ULN
    4. Pregnant or breastfeeding women.
    5. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
    6. Patients planned to receive other investigational treatments during study period
    7. Patients with moderate to severe respiratory impairment
    • Pazienti con cancro metastatico
    • Ipersensibilità nota agli oppioidi , al Fentanil , e ai farmaci usato nella PC-UC (principi attivi ed eccipienti)
    • Pazienti con esami clinici, eseguiti nella normale pratica clinica prima dell’inizio della radioterapia, che hanno evidenziato le seguenti disfunzioni:
    a) Insufficienza epatica:
    - Biliribuna totale > 2 volte il valore soglia massimo
    - Transaminasi sieriche > 5 volte il valore soglia massimo
    b) Insufficienza renale:
    - Creatinina sierica > 2 il valore soglia massimo
    • Donne in gravidanza o allattamento
    • Pazienti che non sono in grado di comprendere lo studio o la natura,
    lo scopo e le possibili conseguenze dei trattamenti in studio.
    • Pazienti che ricevono durante il periodo di studio (o per i quali è stato pianificato ricevere) un altro trattamento sperimentale nell’ambito di un altro studio clinico.
    • Pazienti con moderato o grave danno respiratorio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the difference in the mean intensity of IP-BTP related to swallowing from the baseline to 20 minutes after taking FPNS/PC-UC (PID20).
    Differenza nell’intensità media del dolore alla deglutizione (IP-BTP) tra il baseline e 20 minuti dopo l’assunzione del farmaco (PID20) tra il gruppo trattato con FPNS e quello con PC-UC
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the first bite/sip of the meal, patients will record the pain intensity (baseline pain) according to an 11-NRS; after this, the patient will take the FPNS/PC-UC and wait 10 minutes before start the meal. Pain intensity related to primary efficacy endpoint will be measured at 20 after drug administration.
    The intensity of IP-BTP related to swallowing will be measured 3 times a day (at breakfast, lunch and dinner) by NRS for 15 episodes (no more than 3 episodes / day) in 5/6 consecutive days. The mean PID20 across treatment episodes will be used for the analyses.
    L’intensità del dolore alla deglutizione viene misurata ai 3 pasti principali (colazione, pranzo, cena) per 5/6 giorni consecutivi.
    Ogni paziente raccoglie i dati relativi a 15 episodi di IP-BTP (ogni episodio corrisponde ad un pasto).
    Per ogni pasto il paziente dovrà registrare:
    - il dolore al baseline, ossia al primo boccone o sorso (prima dell’assunzione del trattamento)
    - il dolore durante il pasto registrato a 20 minuti dopo l’assunzione del trattamento.
    E.5.2Secondary end point(s)
    The secondary end points are the evaluation of the effect of FPNS versus PC-UC in respect to:
    • time to reach the maximal pain reduction after administration of FPNS/PC-UC (evaluation of reduction in pain intensity score at each time point: 10,20,30 min after assuming FPNS or PC-UC )
    • clinically meaningful pain reduction
    • patient’s pain relief
    • administration of rescue medication
    • patient’s dysphagia
    • safety and tolerability
    Confrontare le due strategie di trattamento (FPNS vs PC-UC) rispetto a:
    1. Differenza nell’intensità media del dolore alla deglutizione (IP-BTP) tra il baseline e 10, 30 minuti dopo l’assunzione del farmaco
    2. Tempo dopo la somministrazione del farmaco in cui si raggiunge la riduzione massima dell’intensità del dolore rispetto al baseline
    3. Sollievo clinicamente rilevante dal dolore
    4. Sollievo dal dolore riferito dal paziente
    5. Uso di una “terapia di salvataggio” ( dose e frequenza)
    6. Disfagia
    7. Sicurezza e tollerabilità
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary efficacy endpoints are:
    • The difference in the mean intensity of IP-BTP related to swallowing from the baseline to 10 and 30 minutes after taking FPNS/PC-UC.
    • Time to reach the maximal pain reduction after administration of FPNS/PC-UC (at each time point: 10,20,30 min)
    • Patient’s pain relief will be measured at the end of the study period through the 5-points numeric scale.
    • Clinically meaningful pain reduction will be analyzed by assessing percentages of episodes with ≥ 2 point reductions after drug treatment versus baseline
    • Administration of rescue medication (dose and frequency).
    • Patient’s dysphagia assessment. An evaluation of disphagia by MDADI questionnaire will be performed at baseline and at the end of the study period.
    1. Per ogni pasto il paziente dovrà registrare il dolore al baseline e a 10 e 30 min dopo l’assunzione del FPNS/PC-UC.
    2. Il tempo in cui si raggiunge la riduzione massima dell’intensità del dolore: a 10, 20, 30 minuti dopo dopo l’assunzione del FPNS/PC-UC.
    3. Il sollievo dal dolore clinicamente rilevante: la percentuale di episodi in cui si registra una riduzione ≥ 2punti dell’intensità del dolore
    4. Il sollievo dal dolore riferito dal paziente: somministrazione a fine studio di una scala a 5 punti.
    5. La frequenza e la dose della terapia di salvataggio verrà registrata nel periodo di studio
    6. La disfagia: somministrazione al paziente del questionario MDADI al baseline e a fine studio
    7. La sicurezza e tollerabilità dei trattamenti saranno monitorati nei 5/6 giorni di studio.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Trattamento farmacologico utilizzato per il controllo del dolore alla deglutizione nei pazienti con
    Physician choice-Usual care (PC-UC) will be any drug used in the current clinical practice for treat
    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 concerned21
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state158
    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)
    After the end of the study, each patient will be treated according to clinical practice for each center
    Dopo la conclusione dello studio, ogni paziente sarà trattato in accordo alla normale pratica clinica.
    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 Decision2013-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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