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    Summary
    EudraCT Number:2011-002557-56
    Sponsor's Protocol Code Number:ACT11705
    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:2011-12-23
    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 number2011-002557-56
    A.3Full title of the trial
    A randomized, double-blind, parallel-group, placebo-controlled study to assess the clinical benefit of SSR411298 as adjunctive treatment for persistent cancer pain
    Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato vs placebo per valutare il beneficio clinico di SR411298 come trattamento aggiuntivo per il dolore oncologico persistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CANCER PAIN
    DOLORE ONCOLOGICO
    A.4.1Sponsor's protocol code numberACT11705
    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 SponsorSANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT
    B.1.3.4CountryFrance
    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 supportsanofi-aventis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis
    B.5.2Functional name of contact pointcontact point
    B.5.3 Address:
    B.5.3.1Street AddressVle Bodio, 37b
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800.226343
    B.5.5Fax number+39 02.3939.4168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi-aventis.com
    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.3.2Product code SSR411298
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 666860-59-9
    D.3.9.2Current sponsor codeSSR411298
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboTablet
    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
    cancer pain
    dolore oncologico
    E.1.1.1Medical condition in easily understood language
    pain
    dolore
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10027484
    E.1.2Term Metastatic pain
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain, as measured by the change from baseline (baseline = average pain intensity between Visit 1 (Day ­7) and Visit 2 (Day ­1) to end of treatment (end of treatment = average pain intensity during Week 4) in the Numeric Rating Scale (NRS)
    - valutare l’efficacia di SSR411298 200 mg die versus placebo come trattamento aggiuntivo per il dolore oncologico persistente, misurato come variazione della scala numerica NRS (Numeric Rating Scale) tra la visita basale (media delle intensità rilevate tra la visita 1 al giorno -7 e la visita 2 al giorno -1) e la fine del trattamento (media delle intensità rilevate durante la settimana 4)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain, as measured by a variety of secondary efficacy endpoints • To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain • To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment • To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain • To assess endocannabinoid plasma concentrations
    -valutare l’efficacia di SSR411298 200 mg die versus placebo come trattamento aggiuntivo per il dolore oncologico persistente, misurato attraverso gli endpoint secondari di efficacia riportati più avanti -valutare la tollerabilità e la sicurezza di SSR411298 come trattamento aggiuntivo nel dolore oncologico persistente -caratterizzare la malattia del paziente, in termini di tumore, trattamento oncologico, dolore oncologico e trattamento per il dolore oncologico -valutare la farmacocinetica di SSR411298 come trattamento aggiuntivo per il dolore oncologico persistente -valutare le concentrazioni plasmatiche degli endocannabinoidi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with moderate or severe, persistent cancer pain who are receiving World Health Organization (WHO) Step 2 or 3 cancer pain treatment (2) as Background Therapy (BT) - Pain generator must be primarily due to underlying cancer or cancer treatment - Pain generator must be classified as either primarily nociceptive or primarily neuropathic - Pain severity must be moderate or severe, as defined as an NRS score of ≥4 during the SP - World Health Organization Step 2 or 3 cancer pain treatment as BT consists of opioids ± non-opioids ± adjuvants ± rescue therapy for breakthrough pain + For patients with primarily nociceptive cancer pain (NCCP), examples of permitted adjuvant pain treatments are corticosteroids, bisphosphonates, etc, with planned administration to be stable during the study + For patients with primarily neuropathic cancer pain (NPCP), examples of permitted adjuvant pain treatments are antidepressants or antiepileptics, etc, with planned administration to be stable during the study • Signed written informed consent
    •Pazienti con dolore oncologico persistente moderato o severo che stiano ricevendo la terapia antalgica di base (o Background Therapy – BT) per il dolore oncologico del secondo e terzo gradino, della scala analgesica definita dall’OMS, -La causa del dolore deve essere principalmente il tumore o il trattamento oncologico -Il dolore deve essere definito come primariamente nocicettivo o primariamente neuropatico -L’intensità del dolore deve essere di grado moderato o severo, definito da un punteggio NRS≥4, durante il periodo di selezione -Terapia per il dolore oncologico WHO gradino 2 o 3 definita come BT consistente in oppiacei ± non oppiacei ± adiuvanti ± terapia addizionale per il dolore episodico intenso Per pazienti con dolore oncologico principalmente di tipo nocicettivo, esempi di trattamenti adiuvanti permessi sono corticosteroidi, bisfosfonati, ecc., con una somministrazione che si pianifica stabile durante lo studio Per pazienti con dolore oncologico principalmente di tipo neuropatico, esempi di trattamenti adiuvanti permessi sono antidepressivi o antiepilettici, ecc., con una somministrazione che si pianifica stabile durante lo studio •Firma del Consenso informato scritto
    E.4Principal exclusion criteria
    • Instability of pain between Visit 1 (Day ­7) and Visit 2 (Day ­1) • “Satisfied” or “extremely satisfied” response on the 5-point Likert patient satisfaction of pain relief scale at Visit 1 (Day -7) or Visit 2 (Day -1) • Prohibited adjuvant pain treatments in the week prior to Visit 1 (Day ­7) or planned administration during the study - For patients with primarily NCCP, the prohibited adjuvant pain treatments are antidepressants or antiepileptics - For patients with primarily NPCP, antidepressants or antiepileptics are permitted but the simultaneous use of both an antidepressant and antiepileptic is prohibited • Use of tetradydrocannabinol (THC) compounds for the treatment of pain • Chemotherapy within 4 weeks of Visit 1 (Day -7) or chemotherapy planned during the study • Radiotherapy within 4 weeks of Visit 1 (Day ­7) or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted) • Cancer-related surgery within 4 weeks of Visit 1 (Day ­7) or cancer-related surgery planned during the study
    • Instabilità del dolore tra la visita 1 (giorno -7) e la visita 2 (giorno -1) • Risposta alla scala 5-Likert (scala a 5 punti, di rilevazione della soddisfazione del sollievo dal dolore) come ‘Soddisfatto’ o ‘estremamente soddisfatto’ alla visita 1(giorno -7) o alla visita 2 (giorno-1) • Trattamenti adiuvanti non permessi nella settimana precedente alla visita 1 (giorno -7) o pianificati nel periodo di svolgimento dello studio - Per pazienti con dolore primariamente nocicettivo i trattamenti adiuvanti non permessi sono antidepressivi o antiepilettici - Per pazienti con dolore primariamente neuropatico i trattamenti adiuvanti antiepilettici e antidepressivi sono permessi ma non ne è consentito l’uso simultaneo • Utilizzo di composti contententi tetraidrocannabinolo (THC) per il trattamento del dolore • Chemioterapia nelle 4 settimane precedenti alla visita 1 (giorno -7) o chemioterapia pianificata durante il periodo di studio • Radioterapia nelle 4 settimane precedenti alla visita 1 (giorno -7) o radioterapia pianificata durante il periodo di studio (la radioterapia emostatica palliativa è permessa) • Intervento chirurgico per la patologia tumorale nelle 4 settimane precedenti alla visita 1 (giorno -7) o pianificata durante il periodo di studio
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (baseline = average pain intensity between Visit 1 (Day ­7) and Visit 2 (Day ­1) to end of treatment (end of treatment = average pain intensity during Week 4) in the NRS - NRS is a daily assessment performed at the same time each day at the end of the day
    Variazione della scala numerica NRS (Numeric Rating Scale) tra la visita basale (media delle intensità rilevate tra la visita 1 al giorno -7 e la visita 2 al giorno -1) e la fine del trattamento (media delle intensità rilevate durante la settimana 4) - NRS è una valutazione giornaliera eseguita alla stessa ora ogni giorno alla fine della giornata
    E.5.1.1Timepoint(s) of evaluation of this end point
    D-7, D-1 and D28
    G-7, G-1 and G28
    E.5.2Secondary end point(s)
    Efficacy • Brief Pain Inventory Short-Form (BPI­SF) (3,4) • Responder rate: reduction of ≥30% of pain intensity; reduction of ≥50% of pain intensity; pain composite (pain intensity or BT utilization) • Breakthrough pain frequency • Background Therapy utilization: morphine-equivalent dose per day; adjuvant agent utilization; number of rescue medication doses per day • Mood disorders: Hospital Anxiety and Depression Scale (HADS) (5) • Nausea visual analog scale (VAS) • Constipation: Bowel Function Index (BFI) score (6); amount of laxative medication use recorded at each assessment visit • Health care utilization: unscheduled hospitalizations, emergency department visits, healthcare provider office visits and sick leave days • Patient satisfaction of pain relief: 5­point Likert scale • Quality of life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire­C30 (EORTC QLQ­C30) version 3 (7) Safety • Adverse events (AEs) and other clinical and para-clinical parameters (eg, vital signs, physical examination, clinical laboratories, electrocardiography) • Suicidality assessment (Columbia Suicide Severity Rating Scale [C­SSRS]) (8) • Drug Abuse and Liability Assessment (DALA) (9) • Cognitive function tests: Digit-Symbol Substitution Test (DSST) (10), Rey Auditory Verbal Learning Test (RAVLT) (11), and 2­Digit Cancellation Test (2-DCT) (12) • Pill dysphagia assessment Other • SSR411298 plasma concentrations • Endocannabinoid plasma concentrations • SAR250960 urine
    Efficacia -‘Brief Pain Inventory Short-Form’ (BPI-SF) (3,4) -Percentuale di ‘Responder’: valutata come riduzione ≥ 30% dell'intensità del dolore, riduzione ≥ 50% dell'intensità del dolore; dolore composito (valutazione del dolore come intensità del dolore o utilizzo della BT) -frequenza del dolore episodico intenso -utilizzo della terapia BT: misurata come dosi equivalenti di morfina per giorno, utilizzo di terapia adiuvante, numero di dosi di farmaco per la terapia di salvataggio al giorno (rescue terapy) -Disturbi dell'umore: ‘Hospital Anxiety and Depression Scale’ (HADS) (5) -scala analogica visiva (VAS) per la Nausea -Stipsi: Indice della funzione intestinale (BFI) (6): quantitativo di farmaci lassativi usati registrati ad ogni visita di valutazione -Ricorso alle cure sanitarie: ospedalizzazioni non programmate, accessi al pronto soccorso, visite ambulatoriali e assenze per malattia -scala di soddisfazione del paziente che valuta il sollievo dal dolore: ‘5-point Likert scale’ -Qualità della vita: questionario della qualità di vita C30 dell’ ‘European Organization for Research and Treatment of Cancer’ (EORTC QLQ-C30) versione 3 (7) Sicurezza -eventi avversi (AEs) e altri parametri clinici e para-clinici (es. segni vitali, esame fisico, esami di laboratorio, elettrocardiogramma) -valutazione del rischio di suicidio (Columbia Suicide Severity Rating Scale [C-SSRS]) (8) -valutazione alla predisposizione all’abuso di farmaci: ‘Drug Abuse and Liability Assessment’ (DALA) (9) -test delle funzioni cognitive: Digit-Symbol Substitution Test (DSST) (10), Rey Auditory Verbal Learning Test (RAVLT) (11), e 2-Digit Cancellation Test (2-DCT) (12) -Valutazione della difficoltà a deglutire la compressa
    E.5.2.1Timepoint(s) of evaluation of this end point
    From D-7 to D35
    Dal G-7 al G35
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    United States
    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
    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 months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.1.2Preterm 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 180
    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)
    na
    na
    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 Decision2011-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-03-27
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