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    Summary
    EudraCT Number:2011-000023-33
    Sponsor's Protocol Code Number:PIR-BO-11-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000023-33
    A.3Full title of the trial
    Clinical trial to evaluate, in patient suffering of neck pain the therapeutic equivalence, tolerability and satisfaction of subjects treated by medicated plaster containing piroxicam or diclofenac.
    Studio clinico randomizzato, controllato, atto a valutare, in pazienti affetti da dolore muscolare su base osteoartrosica, l'equivalenza terapeutica, la tollerabilita' locale e la soddisfazione verso il trattamento con cerotto medicato contenente piroxicam in confronto al trattamento con cerotto medicato contenente diclofenac.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of therapeutic equivalence, tolerability and patients satisfaction in subjects affected of neck pain treated with medicated plasters containing piroxicam or diclofenac.
    Studio di valutazione dell'equivalenza terapeutica, tollerabilita' e soddisfazione verso il trattamento tra due cerotti medicati, il primo contenente piroxicam ed il secondo diclofenac nel trattamento del torcicollo.
    A.3.2Name or abbreviated title of the trial where available
    PIR-BO-11-001
    PIR-BO-11-001
    A.4.1Sponsor's protocol code numberPIR-BO-11-001
    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 SponsorS.P.A. ITALIANA LABORATORI BOUTY
    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 supportS.P.A. ITALIANA LABORATORI BOUTY
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEDI SERVICE
    B.5.2Functional name of contact pointRICERCA CLINICA
    B.5.3 Address:
    B.5.3.1Street AddressVIA MATTEOTTI, 43 B
    B.5.3.2Town/ cityAGRATE BRIANZA
    B.5.3.3Post code20864
    B.5.3.4CountryItaly
    B.5.4Telephone number039-6057074
    B.5.5Fax number039-6057319
    B.5.6E-mailmedi@mediservice.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 LENOTAC
    D.2.1.1.2Name of the Marketing Authorisation holderI.B.N. SAVIO Srl
    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 Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIROXICAM
    D.3.9.1CAS number 36322-90-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14
    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 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 Yes
    D.2.1.1.1Trade name DICLOREUM TISSUGEL=>DICLOREUM
    D.2.1.1.2Name of the Marketing Authorisation holderALFA WASSERMANN SpA
    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 Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDICLOFENAC HYDROXYETHYLPYRROLIDINE
    D.3.9.1CAS number 119623-66-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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
    cervical pain of osteoarthritic origin
    cervicalgia su base osteoartrosica
    E.1.1.1Medical condition in easily understood language
    neck pain
    torcicollo
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008322
    E.1.2Term Cervicalgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 of piroxicam (applied daily with medicated plaster containing 14 mg) with that of diclofenac (applied twice daily with medicated plaster containing 180 mg) in patients suffering neck pain. Patches will be applied for 8 consecutive days. The clinical efficacy in the two treatment groups (consisting of 120 subjects each) will be assessed by comparing the difference (delta) of pain intensity measured by VAS (Visual Analogue Scale 0-100) at baseline and after 8 days of treatment. The two treatments will be considered equivalent if the difference in the average decrease (baseline - final) of the VAS between the two treatment groups will be less than or equal to 10 mm.
    Comparare, in pazienti affetti da cervicalgia su base osteoartrosica, l’efficacia del piroxicam (applicato giornalmente mediante cerotto medicato contenente 14 mg) con quella del diclofenac (applicato due volte al giorno mediante cerotto medicato contenente 180 mg). Entrambi i cerotti saranno applicati per 8 giorni consecutivi. L’efficacia clinica nei due gruppi di trattamento (costituiti da 120 soggetti ciascuno) sarà valutata confrontando la differenza (delta) dell’intensità del dolore misurata mediante scala VAS (Visual Analogue Scale 0-100) al basale e dopo 8 giorni di trattamento. I due trattamenti saranno considerati equivalenti se la differenza della media del decremento (basale - finale) della scala VAS tra i due gruppi di trattamento sarà inferiore od uguale a 10 mm.
    E.2.2Secondary objectives of the trial
    - Patient satisfaction degree. - Patient compliance. - Assessment of ''responders'' percentage. - Assessment of reduction in average daily pain. - Response time to treatment. - Proportion of patients achieving recovery. - Assessment of skin tolerance in the area of application. - The use of rescue medication to treat pain. - The degree of disability expressed on a verbal scale of 4-point. - The number of episodes in which the patch is partially or completely detached from the evaluated compilation of the diary study. - The percentage of patients who discontinued the study early for dissatisfaction with their assigned treatment.
    - Il grado di soddisfazione verso il trattamento. - La compliance del paziente al trattamento. - Valutazione della percentuale di “responder”. - Valutazione della riduzione media della sintomatologia dolorosa. - Tempo di risposta ai trattamenti rispetto al livello del dolore misurato al basale. - Proporzione di pazienti che raggiunge la guarigione. - Valutazione della tollerabilità cutanea nella zona di applicazione. - L’uso del farmaco rescue per trattare il dolore . - Il grado di disabilità espresso su una scala verbale di 4 punti valutata giornalmente. - Il numero di episodi in cui il cerotto si è parzialmente o completamente distaccato valutata dalla compilazione del diario di studio. - La percentuale di pazienti che hanno interrotto precocemente lo studio per insoddisfazione nei confronti del trattamento loro assegnato.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of cervical pain 2. Male or female aged between 18 and 75 years with a diagnosis of cervical pain(With pain greater than 30 mm on the VAS scale from 0 to 100 mm). 3. Be followed by general practitioners. 4. Being able to read, understand and sign informed consent approved by the Ethics Committee. 5. Accept and be able to fill in the diary study and the VAS
    1. Diagnosi di cervicalgia su base osteoartrosica, effettuata dal medico anche su considerazioni anamnestiche. 2. Maschio o femmina di eta' compresa tra 18 e 75 anni con diagnosi di cervicalgia (con dolore superiore a 30 mm su scala VAS 0- 100 mm ). 3. Essere seguiti da Medici di Medicina generale. 4. Essere in grado di leggere, capire e firmare il consenso informato approvato dal Comitato Etico. 5. Accettare ed essere in grado di compilare il diario di studio e la scala VAS.
    E.4Principal exclusion criteria
    1. Patients with cervical disc disease or due to trauma. 2. Presence of skin lesions in the area of the medicated plaster. 3. Presence of skin diseases within the area of application. 4. Patients with active peptic ulcer, patients with bronchial asthma, a history of gastrointestinal bleeding by nonsteroidal anti-inflammatory drugs. 5. History of alcohol or drug abuse. 6. Known hypersensitivity to piroxicam, diclofenac or to any excipients or other nonsteroidal anti-inflammatory drugs. 7. Known hypersensitivity to paracetamol (rescue medication). 8. Patients taking nonsteroidal anti-inflammatory drugs until 48 hours before inclusion in the study or other drugs with high plasma protein binding. 9. Patients on anticoagulant treatment. 10. Patients who applied topical medication or steroids on the painful area within 48 hours before inclusion. 11. Serious and unstable health conditions, including known and clinically relevant abnormalities in laboratory parameters. 12. Concomitant medical condition that may affect the interpretation of the results of clinical trials. 13. Fertile females. 14. Participation in another clinical trial within 30 days prior to the selection for this protocol. 15. Patients who are doing physical therapy. 16. Patients already included in the present trial
    1. Pazienti con cervicalgie dovute a traumatismi o discopatia. 2. Presenza di lesioni cutanee nella zona di applicazione del cerotto medicato. 3. Presenza di affezioni dermatologiche in atto nella zona di applicazione. 4. Pazienti con ulcera peptica in fase attiva, pazienti con asma bronchiale, anamnesi di emorragia gastrointestinale da farmaci anti-infiammatori non steroidei. 5. Storia di abuso da alcol o sostanze stupefacenti. 6. Nota ipersensibilita' al piroxicam, al diclofenac o ad uno qualsiasi degli eccipienti o ad altri farmaci anti-infiammatori non steroidei. 7. Ipersensibilita' conosciuta al paracetamolo (farmaco rescue). 8. Pazienti che hanno assunto farmaci anti-infiammatori non steroidei fino a 48 ore prima dell’inclusione nello studio o altri farmaci ad elevato legame con proteine plasmatiche. 9. Pazienti in terapia anticoagulante. 10. Pazienti che hanno applicato farmaci topici o farmaci steroidei sulla parte dolorante nelle 48 ore precedenti l’inclusione. 11. Gravi e instabili condizioni di salute, incluse note e clinicamente rilevanti anomalie dei parametri di laboratorio. 12. Patologia medica concomitante che puo' influenzare l’interpretazione dei risultati del trial clinico. 13. Donne fertili. 14. Partecipazione ad un altro studio clinico nei 30 giorni precedenti la selezione per questo protocollo. 15. Pazienti che stanno effettuando terapie fisiche.16Pazienti precedentemente inclusi nel presente studio clinico
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the clinical efficacy in the two treatment groups (piroxicam medicated plaster vs. diclofenac medicated plaster) comparing the difference (delta) of pain intensity measured by VAS (Visual Analogue Scale 0-100) at baseline and after 8-day treatment. The two treatments will be considered equivalent if the difference in the average decrease (baseline - final) of the VAS between the two treatment groups will be less or equal to 10 mm.
    Valutare l’efficacia clinica nei due gruppi di trattamento (cerotto medicato di piroxicam vs. cerotto medicato di diclofenac) confrontando la differenza (delta) dell’intensità del dolore misurata mediante scala VAS (Visual Analogue Scale 0-100) al basale e dopo 8 giorni di trattamento. I due trattamenti saranno considerati equivalenti se la differenza della media del decremento (basale - finale) della scala VAS tra i due gruppi di trattamento sarà inferiore od uguale a 10 mm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    neck pain measured by VAS on day 1 and day 9 (8 days of treatment)
    dolore cervicale tramite scala Vas rilevata al giorno 1 e al giorno 9 (8 giorni di trattamento)
    E.5.2Secondary end point(s)
    - The patient satisfaction degree, expressed by visual analogue scale (VAS) at the end of study visit (V3). - The patient compliance. - Assessment of the percentage of ''responders'', meaning patients showing a pain reduction determined by VAS, at least 30%. - Assessment of reduction in average daily pain measured by VAS scale compilation. - Response time to treatment, meaning ''answering'' a pain reduction of at least 30% on the VAS scale, compared to the level of pain measured at baseline. - Proportion of patients achieving recovery (absence of pain, VAS = 0). - Assessment of the skin tolerability in the application area at day 5 (before application of the fifth patch) and at the end of the study, based on a scale of 8 levels. - The use of rescue medication to treat pain (measured as the amount of patients using rescue medication at least once). - The degree of disability (expressed on a verbal 4-point scale) assessed daily. - The number of episodes in which the patch is partially or completely detached. Data obtained by the diary study. - The percentage of patients who discontinued the study early for dissatisfaction with their assigned treatment.
    - Il grado di soddisfazione verso il trattamento, espresso dal paziente mediante una scala analogico visiva (Scala VAS) durante la visita di fine studio (V3). - La compliance del paziente al trattamento. - Valutazione della percentuale di “responder” cioè i pazienti che mostreranno una riduzione dell’intensità di dolore, determinata mediante scala VAS, pari ad almeno il 30% del valore di intensità di dolore misurato prima del trattamento. - Valutazione della riduzione media della sintomatologia dolorosa rilevata quotidianamente mediante compilazione scala VAS. - Tempo di risposta ai trattamenti, intendendo quale “risposta” una riduzione del dolore di almeno il 30% su scala VAS, rispetto al livello del dolore misurato al basale. - Proporzione di pazienti che raggiunge la guarigione (assenza di dolore, VAS = 0). - Valutazione della tollerabilità cutanea nella zona di applicazione al giorno 5 (prima dell’applicazione del quinto cerotto) ed al termine dello studio sulla base di una scala di valutazione a 8 livelli. - L’uso del farmaco rescue per trattare il dolore (calcolato come quantità totale e come percentuale di pazienti che ricorrono al farmaco rescue almeno una volta). - Il grado di disabilità espresso su una scala verbale di 4 punti (assente, lieve, moderata, severa) valutata giornalmente. - Il numero di episodi in cui il cerotto si è parzialmente o completamente distaccato valutata dalla compilazione del diario di studio. - La percentuale di pazienti che hanno interrotto precocemente lo studio per insoddisfazione nei confronti del trattamento loro assegnato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Satisfaction degree (day 9, V3), patient compliance (every day), assessment of the responders (every day), mean reduction in pain symptoms (every day), response time (every day), patients achieving recovery (every day), assessment of skin tolerance (day 5 and 9, V2 and V3), use of rescue medication (every day), degree of disability (every day), adhesion patch (every day), percentage of patients who discontinued the study for dissatisfaction (day 5 and 9, V2 and V3)
    Grado di soddisfazione (al giorno 9, V3), compliance del paziente (ogni giorno), valutazione dei responder (ogni giorno), riduzione media della sintomatologia dolorosa (ogni giorno), tempo di risposta (ogni giorno), pazienti che raggiungono la guarigione (ogni giorno), valutazione tollerabilità cutanea (ai giorni 5 e 9, V2 e V3), uso del farmaco rescue (ogni giorno), grado di disabilità (ogni giorno), adesività cerotto (ogni giorno), percentuale di pazienti interrotti per insoddisfazione (ai giorni 5 e 9, V2 e V3)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 concerned4
    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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days14
    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.1.1.2Preterm 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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state240
    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)
    This is a study with general practitioners for the symptomatic treatment of neck pain. In case of non-resolution of the disease, patients will follow usual treatment planned by their general practitioner
    Trattasi di studio presso i medici di medicina generale per il trattamento sintomatico della cervicalgia. In caso di non risoluzione della patologia i pazienti entreranno nel percorso terapeutico previsto dal loro medico di medicina generale
    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 Decision2011-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-28
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