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    Summary
    EudraCT Number:2012-000247-27
    Sponsor's Protocol Code Number:AINEP
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-000247-27
    A.3Full title of the trial
    Clinical benefit of diclofenac in patients with acute submassive pulmonary embolism: a randomized clinical trial
    EFICACIA DE DICLOFENACO EN PACIENTES CON TROMBOEMBOLIA DE PULMÓN SUBMASIVA: ENSAYO CLÍNICO ALEATORIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diclofenac for pulmonary embolism
    El diclofenaco para la embolia de pulmón
    A.4.1Sponsor's protocol code numberAINEP
    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 SponsorFundación Investigación Hospital Ramón y Cajal
    B.1.3.4CountrySpain
    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 supportFundación Investigación Hospital Ramón y Cajal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacion Investigación Hospital Ramón y Cajal
    B.5.2Functional name of contact pointFundación Investigación Hospital Ra
    B.5.3 Address:
    B.5.3.1Street AddressCTRA Colmenar Viejo KM 9,100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number3491336882525
    B.5.5Fax number3491336882525
    B.5.6E-mailipablo.hrc@salud.madrid.org
    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 Voltaren
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS 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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDICLOFENAC
    D.3.9.1CAS number 15307-86-5
    D.3.9.3Other descriptive nameVOLTAREN
    D.3.9.4EV Substance CodeSUB07092MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute pulmonary embolism
    Embolismo pulmonar agudo
    E.1.1.1Medical condition in easily understood language
    Acute pulmonary embolism
    Embolismo pulmonar agudo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10037377
    E.1.2Term Pulmonary embolism
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal 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 demonstrate the clinical benefits of diclofenac over placebo in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.
    Demostrar la eficacia de diclofenaco (medida en términos de mejoría de disfunción de ventrículo derecho) en pacientes con tromboembolia de pulmón aguda sintomática submasiva.
    E.2.2Secondary objectives of the trial
    to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction
    evaluar la seguridad del tratamiento con diclofenaco, añadido al tratamiento anticoagulante convencional, en pacientes con tromboembolia de pulmón (TEP) submasiva.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Acute symptomatic PE confirmed by multidetector CT angiography, a high-probability V/Q scan, orbythepresence of deep vein trombosis confirmed by lower limb ultrasound testing in patients with non conclusive V/Q scan;
    2) first symptoms occurring ten days o rless before randomization;
    3) haemodynamic stability (systolic blood pressure> 100 mm Hg, no need of inotropic support, pulmonary resuscitation, intubation o rthrombolytic treatment;
    4) right ventricular dysfunction assessed by transthoracic echocardiography within the first 12 hours after diagnosis of PE;
    5) women of childbearing age should get a negative pregnancy test at screening visit; further agree to use adequate contraception (among them are considered: double barrier as condom + diaphragm, surgical sterilization) within 14 days following administration of study drug.
    6) signed informed consent.
    1) TEP aguda sintomática confirmada mediante angioTC multidetector positivo (19), mediante gammagrafía de ventilación/perfusión de alta probabilidad (20), o mediante gammagrafía de perfusión de intermedia probabilidad asociada a trombosis venosa profunda diagnosticada mediante ecografía de miembros inferiores (21);
    2) inicio de los síntomas en los 10 días anteriores al diagnóstico de TEP;
    3) estabilidad hemodinámica (tensión arterial sistólica > 100 mm Hg, no necesidad de drogas vasoactivas [a criterio del médico responsable del paciente], de reanimación cardiopulmonar, de intubación o de tratamiento trombolítico);
    4) disfunción del ventrículo derecho en la ecocardiografía realizada en las primeras 12 horas tras el diagnóstico de TEP;
    5) las mujeres en edad fértil deberán obtener un resultado negativo en la prueba de embarazo en la visita de selección; además se comprometen a utilizr un método anticonceptivo adecuado (entre ellos se consideran: doble barrera como preservativo + diafragma, esterilización quirúrgica) en los 14 días siguientes a la administración del fármaco en estudio.
    6) firma del consentimiento informado
    E.4Principal exclusion criteria
    1) Previous diagnosis of chronic thromboembolic pulmonary hypertension;
    2) active bleeding, or clinically relevan tbleeding in the previous month before diagnosis of PE;
    4) major surgery, or severe trauma in the previous month before diagnosis of PE;
    5) indication for chronic anticoagulation;
    6) pregnancy o breast feeding;
    7) rena linsufficiency (serum creatinine > 2 mg/dL) or severe hepatic impairment;
    8) hypersensitivity to diclofenac, sodium metabisulfite, or acetilsalicilic acid.
    7) active Crohn's disease
    8) active ulcerative colitis
    9) severe heart failure
    10) a history of bronchial asthma
    11) Patients with severe renal dysfunction
    12) Patients with severe hepatic impairment
    14) Patients with coagulation disorders.
    15) A history of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal antiinflammatory drugs (NSAIDs)
    16) peptic ulcer / active GI bleeding or recurrent (two or more distinct episodes of proven ulceration or bleeding).
    17) Severe heart failure
    1)Diagnóstico previo de hipertensión pulmonar tromboembólica crónica;
    2)sangrado activo o sangrado clínicamente relevante en el mes previo al diagnóstico de TEP;
    3)cirugía mayor, o trauma grave en el mes previo al diagnóstico de TEP;
    4)indicación de anticoagulación distinta al episodio de TEP;
    5)embarazo o lactancia;
    6)enfermedad de Crohn activa
    7)colitis ulcerosa activa
    8)insuficiencia cardíaca grave
    9)antecedentes de asma bronquial
    10)Pacientes con disfunción renal severa
    11)Pacientes con alteración hepática severa
    13)Pacientes con desórdenes de la coagulación.
    14)Antecedentes de hemorragia gastrointestinal o perforación relacionados con tratamientos anteriores con antiinflamatorios no esteroideos (AINEs)
    15)Úlcera péptica /hemorragia gastrointestinal activa o recidivante (dos o más episodios diferentes de ulceración o hemorragia comprobados).
    16)Insuficiencia cardiaca grave
    17)insuficiencia renal (creatinina sérica > 2 mg/dL) o hepática graves;
    18)hipersensibilidad conocida a diclofenaco, a metabisulfito sódico, o a ácido acetilsalicílico.
    E.5 End points
    E.5.1Primary end point(s)
    Right ventricular dysfunction (assessed by transthroacic echocardiography) within 36-48 hours after administration of the first dose of diclofenac/placebo
    disfunción de ventrículo derecho (determinada por ecocardiografía transtorácica) entre las 36-48 horas posteriores a la administración de la primera dosis de diclofenaco/placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36-48h
    36-48h
    E.5.2Secondary end point(s)
    Right ventricular dysfunction (assessed by transthroacic echocardiography) within 7 days after administration of the first dose of diclofenac/placebo
    la disfunción de ventrículo derecho (determinada por ecocardiografía transtorácica) a los 7 días de la administración de la primera dosis de diclofenaco/placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7
    Día 7
    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 No
    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
    Last visit of last enrolled patient
    La última visita del último paciente reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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: 100
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    The treatment will be the expected normal treatment for pulmonary embolism
    El tratamiento será el habitual en pacientes con tromboembolia pulmonar
    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 Decision2012-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
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