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    Summary
    EudraCT Number:2016-004345-85
    Sponsor's Protocol Code Number:369FIBRO-UMH
    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:2017-01-13
    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 number2016-004345-85
    A.3Full title of the trial
    RANDOMIZED CLINICAL TRIAL WITH TWO PATIENT AND PROFESSIONAL PARALLEL MASKS AND AN OPEN GROUP TO VALUE THE EFECTIVENESS AND EFFICIENCY OF HYPERBARIC OXYGENOTHERAPY WITH FOLLOW-UP TO A YEAR IN WOMEN WITH SEVERE OR MODERATE FIBROMYALGIA
    ENSAYO CLINICO ALEATORIZADO CON DOS GRUPOS PARALELOS ENMASCARADOS A PACIENTES Y PROFESIONALES Y UN GRUPO ABIERTO PARA VALORAR LA EFICACIA Y EFICIENCIA DE LA OXIGENOTERAPIA HIPERBÁRICA CON SEGUIMIENTO A UN AÑO EN MUJERES CON FIBROMIALGIA SEVERA O MODERADA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO VALUE THE EFECTIVENESS OF HYPERBARIC OXYGENOTHERAPY IN WOMEN WITH FIBROMYALGIA
    ENSAYO CLÍNICO PARA VALORAR LA EFICACIA DEL USO DE LA OXIGENOTERAPIA HIPERBÁRICA EN MUJERES CON FIBROMIALGIA
    A.3.2Name or abbreviated title of the trial where available
    CLINICAL TRIAL TO VALUE THE EFECTIVENESS OF HYPERBARIC OXYGENOTHERAPY IN WOMEN WITH FIBROMYALGIA
    ENSAYO CLÍNICO PARA VALORAR LA EFICACIA DEL USO DE LA OXIGENOTERAPIA HIPERBÁRICA EN MUJERES CON FIBR
    A.4.1Sponsor's protocol code number369FIBRO-UMH
    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 SponsorHOSPITAL DE PALAMOS
    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 supportHOSPITAL DE PALAMOS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL DE PALAMOS
    B.5.2Functional name of contact pointSECRETARIA TECNICA DE RECERCA
    B.5.3 Address:
    B.5.3.1Street AddressHOSPITAL 27 BAIXOS
    B.5.3.2Town/ cityPALAMOS
    B.5.3.3Post code17230
    B.5.3.4CountrySpain
    B.5.4Telephone number34972609226
    B.5.5Fax number34972609252
    B.5.6E-mailmrovira@ssibe.cat
    D. IMP Identification
    D.IMP: 1
    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.2.1.1.1Trade name Oxígeno Medicinal Líquido Praxair
    D.2.1.1.2Name of the Marketing Authorisation holderPRAXAIR ESPAÑA SLU
    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.3.1Product nameHYPERBARIC OXYGEN
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRespiratory use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.1CAS number 007782-44-7
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    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 Yes
    D.3.11.13.1Other medicinal product typeOXIGENO HIPERBARICO
    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
    FIBROMYALGIA
    FIBROMIALGIA
    E.1.1.1Medical condition in easily understood language
    FIBROMYALGIA
    FIBROMIALGIA
    E.1.1.2Therapeutic area Not possible to specify
    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
    Revised Fibromyalgia Impact Questionnaire (FIQR) average score will be used as primary endpoint in successive evaluations. In this study we consider that treatment with OHB is effective if an improvement of 25% of the average score of FIQR and partially effective between 14-25% is achieved. Thus we assess the effectiveness of OHB in the treatment of fibromyalgia.
    Evaluar la eficacia de la OHB respecto de la práctica habitual para mejorar el estado clínico de los pacientes con fibromialgia moderada o severa, medido mediante una disminución de la puntuación del FIQR en su versión española.
    E.2.2Secondary objectives of the trial
    To assess the efficiency and cost-effectiveness measures consumption of health resources and measures of indirect costs (lost productivity, individual costs of alternative therapies, etc.) will be used.
    Evaluar el coste-efectividad de la aplicación de OHB respecto de la práctica habitual en pacientes con fibromialgia moderada o severa para reducir el consumo de recursos sanitarios y el coste asociado así como de los costes indirectos.
    Evaluar el perfil bioquímico de las citoquinas en la fibromialgia y las modificaciones que la aplicación de la OHB pueda producir.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women; Age: 18 - 65; Fibromyalgia diagnostic criteria using the ACR criteria 2010; Fibromyalgia Diagnosed over 2 years ago; Severity: Valued by FIQR. FIQR > 39
    • Mujer
    • Edad: 18 – 65 años
    • Cumplir Criterios diagnósticos de Fibromialgia utilizando los criterios de la ACR de 2010 (11). Se recogen en el Anexo 1.
    • Diagnosticada de Fibromialgia hace más de 2 años
    • Severidad: Valorada mediante el FIQR (Anexo 2). Se incluirán pacientes con FIQR >39
    E.4Principal exclusion criteria
    Participation in another clinical trial; Pregnancy; she have previously received treatment in hyperbaric chamber or perform diving; Require treatment with OHB during trial; Contraindications for treatment with OHB; neoplasms; Autoimmune rheumatic diseases, Severe mental disorder Inability to sign informed consent; Presence of cognitive impairment (MMSE <27); Smoking
    • Participación en otro ensayo clínico
    • Embarazo
    • Haber recibido anteriormente tratamiento en cámara hiperbárica o realizar submarinismo
    • Necesitar tratamiento con OHB durante la realización del ensayo
    • Contraindicaciones para el tratamiento con OHB
    o Patología pulmonar
    o Enfermedades de oído interno
    o Claustrofobia
    • Neoplasias
    • Enfermedades reumáticas autoinmunes
    • Transtorno mental severo
    • Incapacidad para firmar consentimiento informado
    • Presencia de deterioro cognitivo (MMSE < 27)
    • Fumadores
    E.5 End points
    E.5.1Primary end point(s)
    They will be collected during the study and come from clinical interviews, blood draws and various self-administered patient questionnaires. Each patient will have a total of 6 evaluations first for inclusion in the study and rest for the implementation of the monitoring protocol that will last a total of 61 weeks.
    Se recogerán durante el estudio y provienen de las entrevistas clínicas, extracciones de sangre y de diversos cuestionarios auto-administrados por los pacientes. Cada paciente tendrá un total de 6 evaluaciones la primera para la inclusión en el estudio y el resto durante la aplicación del protocolo de seguimiento que durará un total de 61 semanas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 evaluations first for inclusion in the study and rest for the implementation of the monitoring protocol that will last a total of 61 weeks.
    6 evaluaciones la primera para la inclusión en el estudio y el resto durante la aplicación del protocolo de seguimiento que durará un total de 61 semanas.
    E.5.2Secondary end point(s)
    not applicable
    no aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    no aplica
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 126
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state126
    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 Decision2017-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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