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    Summary
    EudraCT Number:2014-003790-41
    Sponsor's Protocol Code Number:JAN12006-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-02-09
    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 number2014-003790-41
    A.3Full title of the trial
    Randomised, double-blinded, placebo and active comparator controlled exploratory clinical trial to assess the efficacy and safety of a triple combination of Ibuprofen, magnesium and ascorbic acid in Temporo-Mandibular Joint (TMJ) dysfunction syndrome.
    Ensayo clínico exploratorio, aleatorizado, doble-ciego, controlado con placebo y comparador activo, para evaluar la eficacia y seguridad de una triple combinación de ibuprofeno, magnesio y vitamina C, en el tratamiento del dolor agudo en los Trastornos Temporo-Mandibulares (TTM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the clinical effect and safety of a triple combination of ibuprofen, magnesium and vitamin C in the treatment of acute pain in temporomandibular disorders (TMD).
    Ensayo clínico para evaluar el efecto y la seguridad de un nuevo fármaco que combina ibuprofeno, magnesio y vitamina C en el tratamiento del dolor agudo en los Trastornos Temporo-Mandibulares (TTM).
    A.4.1Sponsor's protocol code numberJAN12006-01
    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 SponsorSpherium Biomed
    B.1.3.4CountrySpain
    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 supportSpherium Biomed
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrial Form Support
    B.5.2Functional name of contact pointNoelia Escalona
    B.5.3 Address:
    B.5.3.1Street Addressc/Consell de Cent, 334 -4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08009
    B.5.3.4CountrySpain
    B.5.4Telephone number+34931850200NA
    B.5.5Fax number+34931850257
    B.5.6E-mailnoelia.escalona@tfscro.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.3.1Product nameFDCJAN12006
    D.3.2Product code FDCJAN12006
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNIBUPROFEN D,L-LYSINATE
    D.3.9.1CAS number 57469-76-8
    D.3.9.2Current sponsor codeFDCJAN12006-A
    D.3.9.4EV Substance CodeSUB50818
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMAGNESIUM ASPARTATE
    D.3.9.1CAS number 7018-07-7
    D.3.9.2Current sponsor codeFDCJAN12006-B
    D.3.9.3Other descriptive nameMAGNESIUM ASPARTATE
    D.3.9.4EV Substance CodeSUB14415MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNASCORBIC ACID
    D.3.9.2Current sponsor codeFDCJAN12006-C
    D.3.9.4EV Substance CodeSUB05579MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboPowder for oral solution
    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
    Temporomandibular joint dysfunction syndrome.
    Dolor agudo en los trastornos temporo-mandibulares.
    E.1.1.1Medical condition in easily understood language
    Temporomandibular dysfunction: pain, which is located in the muscles of mastication and the earpiece area, which increases with movement of chewing, speaking or laughing.
    Disfunción témporomandibular: dolor, que está localizado en los músculos de la masticación y en la zona auricular, y que aumenta con los movimientos de la masticación, al hablar o al reír.
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    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 and safety of a triple combination of ibuprofen, magnesium and ascorbic acid (vitamin C) in the treatment of acute pain in TMD compared to placebo.
    Evaluar la eficacia y seguridad de una triple combinación de ibuprofeno, magnesio y ácido ascórbico (vitamina C) en el tratamiento del dolor agudo en los TTM respecto a placebo.
    E.2.2Secondary objectives of the trial
    - To explore the efficacy of a triple combination of ibuprofen, magnesium and ascorbic acid (vitamin C) in improving the functionality of the jaw in the temporomandibular disorders (TTMs) compared to placebo.
    - To explore the efficacy of magnesium and vitamin C in the treatment of acute pain in the temporomandibular (TTMs) disorders compared to placebo.
    - To explore the effectiveness of magnesium and vitamin C in improving the functionality of the jaw in the temporomandibular (TTMs) disorders compared to placebo.
    - Explorar la eficacia de una triple combinación de ibuprofeno, magnesio y ácido ascórbico (vitamina C) en la mejora de la funcionalidad de la mandíbula en los trastornos temporo-mandibulares (TTMs) respecto a placebo.
    - Explorar la eficacia de magnesio y vitamina C en el tratamiento del dolor agudo en los trastornos temporo-mandibulares (TTMs) respecto a placebo.
    - Explorar la eficacia de magnesio y vitamina C en la mejora de la funcionalidad de la mandibula en los trastornos temporo-mandibulares (TTMs) respecto a placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients previously diagnosed or in the screening of TMD who are in acute phase of articular +/- muscle pain (either relapse or onset of pain symptoms), with or without restriction of mouth opening (whether they are carriers of joint stabilization splint or not) (groups the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD) Ia: myofascial pain, Ib: myofascial pain with limited opening +/- IIIa: arthralgia and / or IIIb: osteoarthritis of the temporomandibular joint (TMJ)).
    2) Severity of pain at diagnosis ? 4 VAS assessed by a scale of 10 cm.
    3) Patients aged between 18 and 65 years.
    4) Body mass index (BMI) within the normal range (19 to 30 kg / m2).
    5) Patients who present an ASA physical status I or II (according to the classification of the American Society of Anesthesiologists - ASA).
    6) Patients who have not participated during the three months prior to this study in a previous clinical trial.
    7) Patients who voluntarily participate in the study and sign the informed consent.
    1) Pacientes diagnosticados previamente o en el cribado de inicio del estudio de TTM que se encuentren en fase aguda de dolor muscular +/- articular (ya sea por recidiva o por inicio de la sintomatología dolorosa), con o sin limitación de apertura bucal (tanto si son portadores de férula de estabilización articular como si no) (grupos de The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Ia: dolor miofascial, Ib: dolor miofascial con limitación de apertura +/- IIIa: artralgia y/o IIIb: osteoartritis de la articulación temporomandibular (ATM)).
    2) Intensidad del dolor en el momento del diagnóstico ? 4 según escala EVA de 10 cm.
    3) Pacientes con edades comprendidas entre los 18 y 65 años.
    4) Indice de masa corporal (IMC) dentro del rango de la normalidad (19-30 kg/m2).
    5) Pacientes que presenten un estado físico ASA I o II (según clasificación de la American Society of Anesthesiologists ? ASA).
    6) Pacientes que no hayan participado durante los tres meses previos a este estudio en un ensayo clínico previo.
    7) Pacientes que participen voluntariamente en el estudio y firmen el consentimiento informado.
    E.4Principal exclusion criteria
    1) Patients who plan to become pregnant, are pregnant and / or lactating, or not wishing to use effective contraception (hormonal contraceptives [implementation, patches, oral], and double-barrier methods [any double combination of : IUD, male or female condoms with spermicidal jelly, diaphragm, contraceptive sponge, cervical cap]).
    2) Patients with hypersensitivity or allergy to the investigational product (PEI), or to chemically related products or placebo.
    3)Alcohol or drug dependence history (including history of consumption of psychotropic substances) within 3 months prior to the inclusion visit.
    4) Patients with a high consumption of stimulating beverages (> 5 coffee, tea or cola a day).
    5) Patients who present consumption of enzyme-inducing drugs within 30 days before the study: carbamazepinam, nevirapine, phenobarbital, rifampin, secobarbital and wort
    6) Patients who are taking paracetamol, acetylsalicylic acid, bemiparina, clonixidina, oral anticoagulants, heparin and derivatives, systemic corticosteroids, pemetresed, digoxin, phenytoin, lithium, methotrexate, salicylates, NSAIDs, antacids containing aluminum, as algeldrate, magaldrate, morphine and its derivatives.
    Patients who have been medicated with NSAIDs or morphine derivatives for the treatment of TMD pain before attending the consultation will be included, when they meet a washout period of 8 to 12 hours (depending on the medication they have taken) before being included in the study.
    7) Patients with underlying systemic disease candidate to receive drug treatment with analgesic.
    8) Patients with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs. Peptic ulcer / active or recurrent gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
    9) Patients with Crohn's disease or ulcerative colitis. Severe heart failure. Severe renal dysfunction. Severe hepatic dysfunction.
    10) Patients with oxalate urolithiasis.
    11) Patients with cerebrovascular bleeding or other active bleeding.
    12) Patients with bleeding diathesis or other bleeding disorders
    1) Mujeres potencialmente fértiles que tengan previsto quedarse embarazadas, estén embarazadas y/o en periodo de lactancia, o bien que no deseen utilizar un método anticonceptivo eficaz (anticonceptivos hormonales [implantación, parches, oral], y métodos de doble barrera [cualquier combinación doble de: DIU, profilácticos masculinos o femeninos con gel espermicida, diafragma, esponja anticonceptiva, capuchón cervical]).
    2) Pacientes que presentan hipersensibilidad o alergia al producto en investigación (PEI), a productos relacionados químicamente o al placebo.
    3) Antecedentes de abuso de alcohol o historia de dependencia de drogas (incluyendo historia de consumo de sustancias psicotrópicas) dentro de los 3 meses previos a la visita de inclusión.
    4) Pacientes con un alto consumo de bebidas estimulantes (> 5 cafés, tés o refrescos de cola al día).
    5) Pacientes que presenten un consumo de fármacos inductores enzimáticos dentro de los 30 días previos al estudio: carbamazepinam, nevirapina, fenobarbital, rifampicina, secobarbital y hierba de san Juan
    6) Pacientes que estén consumiendo: paracetamol, ácido acetil salicílico, bemiparina, clonixidina, anticoagulantes orales, heparinas y derivados, los corticosteroides via sistémica,pemetresed, digoxina, fenitoína, litio, metotrexato, salicilatos, AINEs, antiácidos conteniendo aluminio, como algeldrato, magaldrato, morfina y sus derivados.
    Se incluirán los pacientes que se hayan medicado con AINEs o derivados mórficos para el tratamiento del dolor de TTM antes de acudir a la consulta, siempre que cumplan un período de lavado de entre 8 y 12 horas (dependiendo de la medicación que hayan tomado) antes de ser incluídos en el estudio.
    7) Pacientes con patología sistémica de base candidata a recibir tratamiento farmacológico con analgésico.
    8) Pacientes con antecedentes de hemorragia gastrointestinal o perforación relacionados con tratamientos anteriores con AINE. Úlcera péptica/hemorragia gastrointestinal activa o recidivante (dos o más episodios diferentes de ulceración o hemorragia comprobados).
    9) Pacientes con la enfermedad de Crohn o colitis ulcerosa activa. Insuficiencia cardiaca grave. Disfunción renal grave. Disfunción hepática grave.
    10) Pacientes con urolitiasis por oxalato.
    11) Pacientes con hemorragia cerebrovascular u otra hemorragia activa.
    12) Pacientes con diátesis hemorrágica u otros trastornos de la coagulación.
    E.5 End points
    E.5.1Primary end point(s)
    Change in pain severity from baseline and compared to placebo for the triple combination of ibuprofen, magnesium and vitamin C after the 7 days of treatment.
    Pimary safety end points were based on a comparison of the number, severity and causality of adverse events (AEs) between treatment groups.
    Cambio en la intensidad del dolor respecto al nivel basal y comparado con placebo de la triple combinación de ibuprofeno, magnesio y vitamina C a los 7 días de tratamiento.
    Las variables principales de seguridad se basarán en la comparación del número, intensidad y causalidad de los acontecimientos adversos (AA) entre los grupos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the 7 days of treatment.
    A los 7 días de tratamiento.
    E.5.2Secondary end point(s)
    • Change in pain intensity from baseline and compared to placebo for the triple combination of ibuprofen, magnesium and vitamin C at 3 days of treatment.
    • Change in pain intensity from baseline of the triple combination of ibuprofen, magnesium and vitamin C compared to the other three comparators treatments at 3 and 7 days of treatment.
    • Time to onset of pain relief stable (≥ 0.5 measured as a reduction in VAS verified points in at least two consecutive assessments and consistent).
    • Percentage of patients with baseline pain reduction of 10%, 20% and 30% (yes / no), after 3 days of treatment,
    • Percentage of patients with baseline pain reduction of 10%, 20% and 30% (yes / no), after 7 days of treatment.
    • Consumption of rescue medication and time to first use of rescue medication for pain .
    • Evolution in the questionnaire responses RDC / TMD (a clinical examination parameters) collected at baseline, 72 ± 24 h at the final visit at 7 days, comparing the combined treatment group and the placebo two other treatments. The variables in this section will be analyzed in detail are:
    - Unassisted mandibular opening painless (range of vertical movement)
    - Joint Sounds
    - Lateral movements and protrusion
    - Tenderness of extraoral muscles: temporal
    - Tenderness of extraoral muscles: masseter
    - Joint pain on palpation: lateral pole (external)
    - Joint pain on palpation: Back insert (ear canal)
    - Tenderness of intraoral muscles: lateral pterygoid (top retromolar area)
    - Tenderness of intraoral muscles: temporal tendon
    • Cambio en la intensidad del dolor respecto al nivel basal y comparado con placebo de la triple combinación de ibuprofeno, magnesio y vitamina C a los 3 días de tratamiento.
    • Cambio en la intensidad del dolor respecto al nivel basal de la triple combinación de ibuprofeno, magnesio y vitamina c comparado con los otros tres tratamientos comparadores a los 3 y 7 días de tratamiento.
    • Tiempo hasta inicio del alivio del dolor estable (medido como disminución ≥ 0,5 puntos en escala EVA verificada en al menos dos evaluaciones consecutivas y consistentes).
    • Porcentaje de pacientes con reducción del dolor basal del 10%, 20% y 30% (si/no), a los 3 días de tratamiento,
    • Porcentaje de pacientes con reducción del dolor basal del 10%, 20% y 30% (si/no), a los 7 días de tratamiento.
    • Consumo de medicación de rescate y tiempo hasta el primer consumo de medicación de rescate para el dolor..
    • Evolución en las respuestas del cuestionario RDC/TMD (a los parámetros del examen clínico) recogidas en la visita basal, a las 72 ± 24 h y en la visita final a los 7 días, comparando el grupo de tratamiento combinado con placebo y con los otros dos tratamientos. Las variables que dentro de este apartado serán analizadas con detenimiento son las siguientes:
    - Apertura mandibular no asistida sin dolor (rango de movimiento vertical)
    - Sonidos articulares
    - Movimientos de lateralidad y protrusión
    - Dolor a la palpación de los músculos extraorales: temporal
    - Dolor a la palpación de los músculos extraorales: masetero
    - Dolor articular a la palpación: polo lateral (externo)
    - Dolor articular a la palpación: inserción posterior (canal auditivo)
    - Dolor a la palpación de músculos intraorales: pterigoideo lateral (área retromolar superior)
    - Dolor a la palpación de músculos intraorales: tendón del temporal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Specified above.
    Según se especifica arriba.
    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) 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 No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state96
    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)
    None
    Ninguno
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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