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    Summary
    EudraCT Number:2012-001502-26
    Sponsor's Protocol Code Number:TRIAMRAD001
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-14
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2012-001502-26
    A.3Full title of the trial
    Intralesional steroid injection in radiation-induced esophageal strictures
    Injecção intralesional de corticosteróides em estenoses rádicas do esófago
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Steroid injection in esophageal radiation strictures
    Injecção de corticóides em estenoses esofágicas secundárias a radioterapia
    A.4.1Sponsor's protocol code numberTRIAMRAD001
    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 SponsorInstituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
    B.1.3.4CountryPortugal
    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 supportDepartment of Gastroenterology, Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
    B.4.2CountryPortugal
    B.4.1Name of organisation providing supportSociedade Portuguesa de Endoscopia Digestiva (SPED)
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
    B.5.2Functional name of contact pointDepartment of Gastroenterology
    B.5.3 Address:
    B.5.3.1Street AddressRua Professor Lima Basto
    B.5.3.2Town/ cityLisboa
    B.5.3.3Post code1099-023
    B.5.3.4CountryPortugal
    B.5.4Telephone number+3512172298002001
    B.5.5Fax number+351217229855
    B.5.6E-mailmmserrano@gmail.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 Yes
    D.2.1.1.1Trade name TRIGON DEPOT 40 mg/ml suspensión inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 76-25-5
    D.3.9.3Other descriptive nameTRIAMCINOLONE ACETONIDE
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntralesional use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Radiation induced esophageal strictures
    Estenoses rádicas esofágicas
    E.1.1.1Medical condition in easily understood language
    Esophageal radiation strictures
    Estenoses esofágicas secundárias a radioterapia
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10048900
    E.1.2Term Radiation esophagitis
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10030195
    E.1.2Term Oesophageal stenosis acquired
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the number of dilations required to maintain a dysphagia score 0-1, during a 12 months period in patients trearted with triamcinolone in comparison with placebo.

    Comparar o número de dilatações necessárias para manter um grau de disfagia de 0 ou 1, num período de 12 meses, em doentes que recebem triamcinolona vs placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of with triamcinolone in comparison with placebo in what regards:
    - Compare the dysphagia grade at 2 weeks after the first esophageal dilation;
    - Compare the mean time between first and second dilation, to maintain a dysphagia grade 0-1;
    - In patients submitted to 3 dilations with injection, compare the mean time between the third and the fourth dilation and the grade of dysphagia 3 weeks after the third dilation;
    - Compare the mean time between dilations, in the period of 12 months, to maintain a dysphagia grade of 0-1.
    - Comparar o grau de disfagia às 2 semanas após 1 dilatação esofágica com injecção de triamcinolona vs placebo;
    - Comparar o tempo médio entre a 1ª e a 2ª dilatação, para manter um grau de disfagia de 0 ou 1, em doentes que recebem triamcinolona vs placebo;
    - Nos doentes que fizerem 3 dilatações com injecção, comparar o tempo médio entre a 3ª e a 4ª dilatações e o grau de disfagia 2 semanas após a 3ª dilatação;
    - Comparar o tempo médio entre dilatações, num período de 12 meses, para manter um grau de disfagia de 0 ou 1 em doentes que recebem triamcinolona vs placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Obtaining informed consent;
    2. Age >18 years;
    3. Radiation-induced esophageal (or hipopharynx) stricture:
    - previously dilated to a diameter equal or superior to 12 mm and requiring at least one new dilation session over a period of 12 months or
    - impossibility of dilation up to 12 mm after two dilatation sessions with 2 weeks apart;
    4. Dysphagia grade >1
    1. Obtenção de consentimento informado;
    2. Idade >18 anos;
    3. Estenose rádica do esófago (ou hipofaringe):
    - previamente dilatada até diâmetro igual ou superior a 12mm e com necessidade de pelo menos uma nova dilatação num período de 12 meses ou
    - impossibilidade de dilatação até 12 mm após duas sessões de dilatação com 2 semanas de intervalo;
    4. Grau de disfagia >1.
    E.4Principal exclusion criteria
    1. Inability to provide informed consent;
    2. Allergy to triamcinolone;
    3. Severe disease that prevents deep sedation;
    4. Thrombocytopenia (platelets <50000/μL) or coagulation disorders (prothrombin rate <60%);
    5. Radiation-induced strictures with an ulcerated component.
    1. Incapacidade de fornecer consentimento informado;
    2. Alergia à triamcinolona;
    3. Doença grave que impeça a sedação profunda;
    4. Trombocitopénia (plaquetas <50000/μL) ou alterações da coagulação (taxa de protrombina <60%);
    5. Estenoses rádicas com componente ulcerado.
    E.5 End points
    E.5.1Primary end point(s)
    Number of dilations required to maintain a dysphagia grade of 0 or 1 (Ogilvie score)
    Número de dilatações necessárias para manter um grau de disfagia de 0 ou 1 (score de Ogilvie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Schedule follow-up:
    • Clinical visits: 3 months and 12 months (end of study).
    • Phone call: 1 week, 2 weeks, 1 month, 2 months, 4 months, 6 months, 9 months and SOS if dysphagia / worsening dysphagia
    Cronograma do seguimento clínico:
    • Visitas clínicas: 3 meses e 12 meses (final do estudo).
    • Contacto telefónico: 1 semana, 2 semanas, 1 mês, 2 meses, 4 meses, 6 meses, 9 meses e em SOS se disfagia/agravamento de disfagia
    E.5.2Secondary end point(s)
    - Dysphagia grade at 2 weeks after the first esophageal dilation (Ogilvie score);
    - Mean time between first and second dilation, to maintain a dysphagia grade 0-1;
    - In patients submitted to 3 dilations with injection, compare the mean time between the third and the fourth dilation and the grade of dysphagia 3 weeks after the third dilation;
    - Mean time between dilations, in the period of 12 months, to maintain a dysphagia grade of 0-1.
    - Grau de disfagia às 2 semanas após 1 dilatação esofágica (score de Ogilvie);
    - Tempo médio entre a 1ª e a 2ª dilatação, para manter um grau de disfagia de 0 ou 1;
    - Nos doentes que fizerem 3 dilatações com injecção, comparar o tempo médio entre a 3ª e a 4ª dilatações e o grau de disfagia 2 semanas após a 3ª dilatação;
    - Tempo médio entre dilatações, num período de 12 meses, para manter um grau de disfagia de 0 ou 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Schedule follow-up:
    • Clinical visits: 3 months and 12 months (end of study).
    • Phone call: 1 week, 2 weeks, 1 month, 2 months, 4 months, 6 months, 9 months and SOS if dysphagia / worsening dysphagia
    Cronograma do seguimento clínico:
    • Visitas clínicas: 3 meses e 12 meses (final do estudo).
    • Contacto telefónico: 1 semana, 2 semanas, 1 mês, 2 meses, 4 meses, 6 meses, 9 meses e em SOS se disfagia/agravamento de disfagia
    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 No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 (12 months after randomization of the last patient)
    LVLS (12 meses após aleatorização do último doente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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.1.1.1In 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state28
    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 trial participation, patients will be treated according to standard of care for this condition.
    Após conclusão do estudo os doentes serão tratados de acordo com os procedimentos habituais estabelecidos na instituição.
    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 Decision2012-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-28
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