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   43883   clinical trials with a EudraCT protocol, of which   7296   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:2011-005007-33
    Sponsor's Protocol Code Number:BIBEC02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-21
    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 number2011-005007-33
    A.3Full title of the trial
    A multicenter, randomized, double-blind, parallel groups, placebo-controlled trial to evaluate efficacy and safety of a new i.v. formulation of ibuprofen 800 mg every 6 hours in the management of postoperative pain.
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la eficacia y seguridad de una nueva formulación de ibuprofeno IV 800 mg cada 6 horas para el manejo del dolor postoperatorio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess efficacy and safety of a new formulation of ibuprofen 800 mg in the treatment of postoperative pain.
    Ensayo clínico para evaluar la eficacia y seguridad de una nueva formulación de ibuprofeno 800 mg en el tratamiento del dolor postoperatorio.
    A.4.1Sponsor's protocol code numberBIBEC02
    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 SponsorLaboratorios Biomendi S.A.U.
    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 supportLaboratorios Biomendi S.A.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Biomendi S.A.U.
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressPol. Ind. de Bernedo, s/n
    B.5.3.2Town/ cityBernedo, Álava
    B.5.3.3Post code01118
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491710-40-07NA
    B.5.5Fax number+3491710-36-30NA
    B.5.6E-mailiortuzar@gesgenericos.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 nameIbuprofen Biomendi 4mg/mL
    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 INNIBUPROFEN
    D.3.9.1CAS number 15687-27-1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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/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
    Moderate to severe postoperative pain.
    Dolor postoperatorio de intensidad moderada a grave.
    E.1.1.1Medical condition in easily understood language
    Postoperative pain.
    Dolor postoperatorio.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain.
    Estudiar la eficacia de la administración de ibuprofeno intravenoso comparada con placebo en pacientes con dolor postoperatorio.
    E.2.2Secondary objectives of the trial
    To evaluate the tolerability and safety profile.
    Evaluar la tolerabilidad y seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women between 18 and 80 years old.
    2. Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement), or abdominal surgery (inguinal hernia, cholecystectomy).
    3. Being scheduled for general anaesthesia.
    4. Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
    5. Expected to stay at the hospital for at least 24 h.
    6. Providing written informed consent for participating in this study.
    1. Hombre o mujer de 18 a 80 años.
    2. Haber sido programados para cirugía ortopédica (prótesis de cadera o rodilla) o abdominal (herniorrafia inguinal o colecistectomía).
    3. Que vaya a ser intervenido con anestesia general.
    4. Que se prevea que van a precisar analgesia postoperatoria con opioides administrado por el propio paciente (PCA o analgesia controlada por el paciente).
    5. Que vayan a permanecer en el hospital durante las 24 h siguientes a la cirugía.
    6. Que otorgue el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Use of NSAID within 12 hours prior to the first planned dose.
    2. Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
    3. Anaemia and/or history or evidence of asthma or heart failure.
    4. History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
    5. Pregnant or nursing.
    6. Weight less than 40 kg.
    7. History of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.
    8. History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
    9. Gastrointestinal bleeding that required medical intervention.
    10. Peptip ulcer antecedents or inflammatory bowel disease.
    11. Patients with severe cardiac insufficiency and/or ischemic cardiomyopathy.
    12. Platelet count less than 80.000 determined within the 28 days prior to surgery.
    13. Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
    14. Severe renal failure.
    15. Liver failure, ALAT or ASAT > 3 times upper limit of normality, or bilirrubin > 2 g/dl.
    16. Diagnosed of Bowel Inflammatory Disease.
    17. Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.
    1. Uso de antiinflamatorios no esteroideos (AINE) en las 12 h previas a la administración de la primera dosis del estudio.
    2. En tratamiento con anticoagulantes orales, litio, combinaciones de furosemida e inhibidores de la enzima convertidora de angiotensina, o aspirina.
    3. Anemia y/o antecedentes o evidencia actual de asma o insuficiencia cardiaca.
    4. Antecedentes de alergia o hipersensibilidad a cualquiera de los componentes de la formulación de ibuprofeno intravenoso, aspirina o productos relacionados, otros AINE (incluyendo inhibidores de la COX-2).
    5. Embarazo o lactancia.
    6. Peso menor de 40 kg.
    7. Antecedentes de traumatismo craneoencefálico severo con ingreso hospitalario, cirugía intracranial o ictus en los 30 días previos al inicio del estudio, así como antecedentes de malformación arteriovenosa, aneurismas o lesiones ocupantes de espacio a nivel cerebral.
    8. Antecedentes de diátesis hemorrágica congénita o cualquier hemorragia activa clínicamente relevante, así como antecedentes de disfunción plaquetaria subyacente.
    9. Antecedentes de hemorragia gastrointestinal que haya precisado intervención médica.
    10. Antecedentes de Ulcus péptico o enfermedad inflamatoria intestinal.
    11. Pacientes con insuficiencia cardiaca grave y/o cardiopatía isquémica.
    12. Recuento plaquetario menor de 80.000 dentro de los 28 días previos a la cirugía.
    13. Dependencia de narcóticos o tratamiento crónico con opioides.
    14. Insuficiencia renal.
    15. Insuficiencia hepática, ALAT o ASAT > 3 veces el límite superior de la normalidad o bilirrubina > 2g/dl.
    16. Diagnóstico de enfermedad inflamatoria intestinal.
    17. Sin capacidad para comprender los requerimientos del estudio, o que no esté dispuesto a acatar las restricciones del estudio o a acudir a las visitas necesarias.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in total morphine use in the first 24 hours post-surgery as compared to placebo.
    Reducción en el uso de morfina en las primeras 24 horas en comparación con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after surgery
    24 horas tras cirugía
    E.5.2Secondary end point(s)
    - Consumption of morphine in the first 48 h (and 72 h) post-surgery.
    - Pain intensity at rest and with movement measured with the eleven points visual analogue scale (VAS).
    - Ramsay-Hunt sedation scale.
    - Time to first subsequent narcotic analgesia (or time to treatment failure).
    - Number of doses of morphine and number of attempts of dosing at PCA.
    - Nocturnal awakenings due to pain.
    - Adverse events during the study.
    - Local reactions due to IV infusion.
    - Vital signs.
    - Routine laboratory tests.
    - Reducción en el consumo de morfina a las 48 h (y 72h) postcirugía.
    - Intensidad del dolor en reposo y con movimiento medido a través de la Escala Visual Analógica (EVA9.
    - Escala de sedación de Ramsay-Hunt.
    - Tiempo hasta la administración de la primera dosis de analgesia de rescate (o tiempo hasta el fracaso del tratamiento).
    - Número de dosis de morfina y número de intentos de dosis de morfina en PCA.
    - Despertares nocturnos por dolor.
    - Efectos adversos durante el estudio.
    - Reacciones locales en el lugar de inyección.
    - Constantes vitales.
    - Analíticas de rutina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between 2-4 days after last ibuprofen dose.
    De 2 a 4 días después de la última dosis de ibuprofeno.
    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 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 trial2
    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 concerned9
    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 patient last visit.
    Última visita del último paciente.
    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 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state320
    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)
    Expected normal treatment.
    Tratamiento habitual según práctica clínica.
    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 Decision2012-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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-Tue May 21 05:26:21 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA