Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-024298-37
    Sponsor's Protocol Code Number:ESOT/1/2010
    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:2012-02-28
    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 number2010-024298-37
    A.3Full title of the trial
    Early strong opiod treatment in cancer pain -Morphine vs weak opiods
    Studio ESOT-M - Valutazione comparativa di strategie farmacologiche per la gestione del dolore nel paziente oncologico
    A.3.2Name or abbreviated title of the trial where available
    ESOT-M
    ESOT-M
    A.4.1Sponsor's protocol code numberESOT/1/2010
    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 SponsorDipartimento Integrato di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 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.3.8INN - Proposed INNMorphine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number30
    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.2.1.2Country 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 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.3.8INN - Proposed INNTramadol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 3
    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.2.1.2Country 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 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.3.8INN - Proposed INNCodeine, combinations excl. psycholeptics
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number30
    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: 4
    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.2.1.2Country 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 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.3.8INN - Proposed INNTramadol, combinations
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number37.5
    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
    Tumor Pain, mild-moderate intensity (VAS 3-7)
    Dolore oncologico di intensita' lieve-moderata (VAS 3-7)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    The primary objective of the study is to obtain definitive and scientifically valid information about a very common clinical practice in cancer pain management such as early use of strong opioid analgesics, comparing this treatment with that of the second step of WHO analgesic ladder (weak opioids). This objective is achieved by evaluating the rate of responders to each treatment, ie the rate of patients that show a 20% difference in average pain intensity, measured on a 0 to 10 scale, comparing the baseline score with the score at day 28 for each study arm.
    Acquisire informazioni definitive e scientificamente affidabili su una pratica clinica molto frequente nella gestione del dolore di intensita' lieve-moderata nel paziente oncologico, quale l’uso precoce e a bassi dosaggi di farmaci del III gradino OMS (i cosiddetti oppioidi forti, tra i quali la morfina e' stata identificata come il farmaco di riferimento). Nello specifico si vuole confrontare tale pratica con quella prevista dalla scala analgesica OMS, vale a dire l’uso dei farmaci del II gradino, anch’esso normalmente applicato nella pratica clinica corrente. Tale obiettivo si raggiunge esaminando in maniera comparativa la frazione di pazienti responder ai due trattamenti, ovvero i pazienti che dopo 28 giorni di trattamento presentano una riduzione dell’intensita' media del dolore del 20% rispetto al baseline.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to integrate information on the effectiveness of two treatments by evaluating: changes in the dosage of drugs administered, the use of rescue therapies and/or adjuvant drugs, the possible occurrence of serious adverse events, the symptoms measured by the total scale ESAS, the discontinuation for inefficacy or toxicity.
    Confrontare le due strategie di trattamento rispetto a: 1. Variazioni del dosaggio del farmaco oppioide (Indice di incremento della dose di oppioidi, Opioid Escalation Index, OEI) 2. Utilizzo di una terapia di salvataggio (rescue dose) 3. Utilizzo di farmaci adiuvanti 4. Profilo di sicurezza e tollerabilita' 5. Variazione della sintomatologia complessivamente misurata attraverso la scala ESAS (vedi allegato A) 6. Interruzione della terapia per inefficacia o tossicita' 7. Valutazione della risposta analgesica completa alla fine dei 28 giorni di follow-up, sulla base della frazione di pazienti che mostrano un miglioramento significativo (&gt;30%) e altamente significativo (&gt;50%) dell’intensita' media del dolore tra la visita finale (a 28 giorni dall’inclusione) e quella al basale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=18 years, both male and female • Patients with (solid or hematologic) cancer, at any stage of the disease • Patients able to take oral medications • Patients with mild-moderate average daily pain during the previous 24 hours, ie between 3 and 7 measured using a Numerical Rating Scale (NRS) to 11 levels (0-10) • Opioid-naïve patients, ie patients who at inclusion in the study are not receiving opioid analgesics or who do not receive chronic opioid analgesics around the clock • Patients with life expectancy greater than 3 months • Patients with good performance status (Karnofsky ≥ 60) • Patients who, in the opinion of the clinician, ensure ''compliance'' to the protocol for cognitive performace and lack of psychiatric illness • Patients who give written informed consent for participation
    • Eta' &gt;=18 anni, di entrambi i sessi • Pazienti affetti da tumore (solido o ematologico), in qualsiasi stadio della malattia, con dolore oncologico, definito come dolore dovuto a malattia oncologica, manovre chirurgiche, trattamenti specifici • Pazienti in grado di assumere farmaci per via orale • Pazienti con dolore medio giornaliero, riferito alle 24 ore precedenti, di intensita' lieve-moderata, cioe' compresa tra 3 e 7, misurata utilizzando la Numerical Rating Scale (NRS) a 11 livelli (0-10), dove 0=”nessun dolore” e 10=“il peggior dolore immaginabile” • Pazienti opioidi-naïve, ovvero pazienti che al momento dell’inclusione nello studio non sono in trattamento con analgesici oppioidi o che non ricevono cronicamente analgesici oppioidi ad orari fissi • Pazienti con aspettativa di vita superiore a 3 mesi • Pazienti con un buon performance status (Karnofsky ≥ 60) • Pazienti che, secondo il parere del clinico, garantiscono un’adeguata “compliance” al protocollo per performace cognitivo e assenza di patologia psichiatrica • Pazienti che danno il loro consenso informato per la partecipazione allo studio
    E.4Principal exclusion criteria
    • Chronic renal failure, grade 4 or 5 • Severe hepatic impairment • Severe respiratory insufficiency • Patients with malabsorption syndrome • Patients with diarrhea and/or nausea and vomiting due to specific cancer treatments • Patients with sub-ileus or bowel obstruction for whom oral opioids are not indicated • Contraindications to the use of any type of opioid drugs • Patients at inclusion are following a course of radiotherapy or radioiodine therapy to obtain pain relief, or for whom such treatment was completed less than 14 days or is planned in the next 4 weeks • Inclusion in other experimental studies
    • Insufficienza renale cronica di grado 4 o 5 (filtrato glomerulare &lt; 30ml/minuto) • Insufficienza epatica grave • Insufficienza respiratoria severa • Pazienti che non siano in grado di assumere una terapia orale • Pazienti con sindrome da malassorbimento • Pazienti con diarrea e/o nausea e vomito da terapie oncologiche specifiche • Pazienti con occlusione o subocclusione intestinale per i quali gli oppioidi orali non sono indicati • Pazienti che, secondo il parere del clinico, non garantiscono un’adeguata compliance al protocollo per deterioramento cognitivo o patologia psichiatrica • Controindicazioni di qualsiasi natura all’uso dei farmaci oppioidi • Pazienti che al momento dell’inclusione stanno seguendo un ciclo di radioterapia o di terapia radiometabolica a scopo antalgico, o per i quali tale trattamento si e' concluso da meno di 14 giorni o e' previsto nelle successive 4 settimane • Inclusione in altri studi sperimentali
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point of the study is the difference of the proportion of responders to treatment, comparing patients treated with morphine at low doses (step III WHO) and those treated with weak opioids (step II WHO).
    Analisi della differenza tra il gruppo trattato con morfina a bassi dosaggi (“III gradino OMS”) e quello trattato con oppioidi deboli (“II gradino OMS”) della proporzione di pazienti responder al trattamento dopo 28 giorni dall’inclusione nello studio. Per la definizione di responder v. punto 2.1.
    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 concerned42
    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
    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
    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.1.3Elderly (>=65 years) Yes
    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 state426
    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 Decision2011-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA