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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2011-004775-36
    Sponsor's Protocol Code Number:DETOX-11
    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:2011-12-22
    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 number2011-004775-36
    A.3Full title of the trial
    ''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms during opioid detoxification''
    ''Studio di fase III, multicentrico, in aperto, per valutare l'efficacia e la sicurezza di differenti schemi posologici di Lofexidina cloridrato 0,2 mg (DIMATEX), nel trattamento dei sintomi astinenziali in corso di detossificazione da oppiacei''
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III clinical study, performed in several sites to evaluate the efficacy and safety of the drug Lofexidine in opiate addicts (heroin, methadone and buprenorphine)which are expected to participate in a detoxification program.
    Studio clinico di fase III, effettuato in piu' centri, per valutare l'efficacia e la sicurezza del farmaco Lofexidina in soggetti dipendenti da oppiacei (eroina, metadone e buprenorfina) per i quali e' prevista la partecipazione in un programma di disintossicazione.
    A.4.1Sponsor's protocol code numberDETOX-11
    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 SponsorGET SRL
    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 supportGET SRL
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFEDERSERD
    B.5.2Functional name of contact pointSEGRETERIA ORGANIZZATIVA
    B.5.3 Address:
    B.5.3.1Street AddressVia Matteotti, 3
    B.5.3.2Town/ cityMariano Comense (Co)
    B.5.3.3Post code22066
    B.5.3.4CountryItaly
    B.5.4Telephone number031748814
    B.5.5Fax number031751525
    B.5.6E-mailfederserd@expopoint.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 DIMATEX*60CPR RIV 0,2MG
    D.2.1.1.2Name of the Marketing Authorisation holderC.T. LAB.FARMACEUTICO 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 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 INNLOFEXIDINE HYDROCHLORIDE
    D.3.9.1CAS number 21498-08-8
    D.3.9.4EV Substance CodeSUB02966MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oppiate addicts(heroin, methadone and buprenorphine)
    Dipendenza da Oppiacei (eroina, metadone e buprenorfina)
    E.1.1.1Medical condition in easily understood language
    Drug addiction from heroin, methadone and buprenorphine
    Tossicodipendenza da eroina, metadone e buprenorfina
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10032707
    E.1.2Term Other specified drug dependence, continuous use
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    a) To confirm the tollerability and safety profile with the use of Lofexidine during the entire time of treatment. b) To evaluate Lofexidine efficacy undergoing drug free detoxification.
    a) Confermare il profilo di tollerabilità e di sicurezza d’uso di Lofexidina per tutta la durata del trattamento. b) Valutare l’efficacia di Lofexidina nel processo di detossificazione drug-free.
    E.2.2Secondary objectives of the trial
    To evaluate if Lofexidine standard dosage used in English clinical practice, can be used in italian detoxification centre (Ser.T e/o Presidi delle tossicodipendenze nelle Carceri e/o Unità Operative Ospedaliere)undergoing a drug free detoxification process from heroin, methadone, buprenorphine and buprenorphine/naloxone.
    Valutare se lo schema posologico standard di Lofexidina utilizzato nella pratica clinica inglese possa essere utilizzato in maniera soddisfacente nei servizi italiani per le tossicodipendenze (Ser.T e/o Presidi delle tossicodipendenze nelle Carceri e/o Unità Operative Ospedaliere) in un processo di detossificazione drug-free da eroina, metadone, buprenorfina o buprenorfina/naloxone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a)Mail and femal between 18 and 60 years. b)Subjects addicted from heroin follwing DSM-IV criteria, whom have already been decided the inclusion in a fast detoxification program or Subjects addicted from heroin following DSM IV criteria treated with methadone maintenance treatement(< 40 mg/die) o buprenorphine (< 8 mg/die) o buprenorphine/naloxone (< 8 mg/die)undergoing a drug free detoxification process from heroin, methadone, buprenorphine and buprenprphine/naloxone. c) Subjects with positive urine test for heroin and syntesis opiate (methadone, buprenorphine) and negative for other drugs. d) Subjects with laboratory results that must have non clinical significant results that could interfire with the study conduction and evaluation. e) Subjects able to understand and sign the Informed Consent form.
    a) Uomini e donne di età compresa tra 18 e 60 anni. b)Soggetti diagnosticati come dipendenti da eroina in base ai criteri del DSM-IV, per i quali sia stato già preventivamente deciso l’inserimento in un programma rapido di detossificazione; oppure Soggetti diagnosticati come dipendenti da eroina in base ai criteri del DSM-IV ed in corso di trattamento di mantenimento con metadone (&lt; 40 mg/die) o buprenorfina (&lt; 8 mg/die) o buprenorfina/naloxone (&lt; 8 mg/die), per i quali sia stato già preventivamente deciso l’inserimento in un programma di detossificazione da oppiacei. c)Soggetti con screening tossicologico delle urine positivo per eroina e oppiacei di sintesi (metadone, buprenorfina) e negativo per altre sostanze. d)Soggetti con risultati di laboratorio che devono essere privi di anomalie clinicamente significative che potrebbero interferire con la conduzione e valutazione dello studio. e)Soggetti capaci e disponibili a comprendere e firmare un Consenso Informato scritto
    E.4Principal exclusion criteria
    a)Subjects with blood pressure < 90/60 mm/Hg and/or in treatement with hypotensive drug. b)Subsects with heart insufficiency(NYHA, classe II)or resting heart frequency < 55 bpm or severe cardiac disorders during anamnesis. c)Subjects with diabetes mellitus. d)Subjects with significant liver disease (AST and/or ALT > 3N). e) Subjects positiv to HBV and /or HCV in pharmacological treatment. f)Subjects with gastric disease that could change the absorption of study drug. g)Subjects with asthma in chronic treatment. h) Subjects with severe psychiatric disorders including psychosis, bipolar disorder, schizophrenia, depression. j)Epileptics or subjects that have been treated with anticonvulsants in the last 3 years. k)Non-compliance during the study, in accordance with the Investigator opinion.
    a)Soggetti con valori di pressione arteriosa &lt; 90/60 mm/Hg e/o in terapia con farmaci ipotensivi. b)Soggetti con insufficienza cardiaca (NYHA, classe II) o frequenza cardiaca a riposo &lt; 55 bpm o grave cardiopatia in anamnesi. c)Soggetti con diabete mellito. d)Soggetti con patologie epatiche significative (valori di AST e/o ALT &gt; 3N). e)Soggetti HBV e/o HCV positivi e in trattamento farmacologico. f)Soggetti con patologie gastriche tali da alterare significativamente l’assorbimento del farmaco in studio. g)Soggetti asmatici in trattamento cronico. h)Soggetti con gravi patologie psichiatriche incluse psicosi, disturbi bipolari, schizofrenia, depressione maggiore. i)Soggetti epilettici o che siano stati in terapia con anticonvulsivanti negli ultimi 3 anni. j)Soggetti con test per HIV positivo. k)Soggetti potenzialmente non collaborativi durante lo studio, secondo il giudizio dello Sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    a) Frequency and type of adverse events. b) Quantification of withdrawal symptoms by SOWS scale and evaluation of the ''craving'' by VAS scale.
    a) Frequenza e tipo di eventi avversi. b) Quantificazione dei sintomi di astinenza tramite SOWS e valutazione del craving tramite VAS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be observed at each visit from the first treatment administration. Withdrawal and ''craving'' will be observed for each day of treatment.
    Gli eventi avversi verranno rilevati ad ogni visita a partire dall'inizio del trattamento; L'astinenza e il ''craving'' verranno rilevati per ogni giorno di trattamento.
    E.5.2Secondary end point(s)
    1)Number of patients who completed treatment 2)Number of subjects relapsed to opiate use during follow-up.
    a) Numero di pazienti che hanno concluso il trattamento. b) Numero di soggetti ricaduti nell’uso di oppiacei durante il follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)Number of patients who completed treatment will be observed at the end of treatment 2)Number of subjects relapsed to opiate use during follow-up will bw observed after the follow-up
    a) Il numero di pazienti che concluderà il trattamento verrà rilevato alla fine del trattamento b)Numero di soggetti ricaduti nell’uso di oppiacei durante il follow-up verrà rilevato al termine del follow-up.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial3
    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 concerned20
    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 months17
    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.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Prisoners
    Detenuti
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation FeDerSerD
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-21
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 11:34:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA