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    Summary
    EudraCT Number:2005-003360-26
    Sponsor's Protocol Code Number:KF0151Y/07 incluida enmienda (A)1.0
    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:2005-12-12
    Trial results View 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 number2005-003360-26
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, en grupos paralelos para evaluar la eficacia analgésica y la seguridad de diferentes dosis de GRT0151Y bid en comparación con un comparador activo bid y placebo bid en pacientes con artrosis crónica de rodilla.
    A.4.1Sponsor's protocol code numberKF0151Y/07 incluida enmienda (A)1.0
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratorios Andromaco, S.A.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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.3.2Product code GRT0151Y capsule
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAxomadol hydrochloride
    D.3.9.1CAS number 187219-95-0
    D.3.9.2Current sponsor codeGRT0151Y
    D.3.9.3Other descriptive nameBN110
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number56.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Information not present in EudraCT
    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.3.2Product code GRT0151Y capsule
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAxomadol hydrochloride
    D.3.9.1CAS number 187219-95-0
    D.3.9.2Current sponsor codeGRT0151Y
    D.3.9.3Other descriptive nameBN110
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number84.8
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 3
    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 Information not present in EudraCT
    D.2.1.1.1Trade name OxyContin® 10 mg comprimidos recubiertos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameOxyContin® 10 mg comprimidos recubiertos de liberación prolongada
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNOxycodone hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboCapsule*
    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
    Artrosis de rodilla (Osteoarthritis of the knee).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia analgésica y la seguridad de múltiples administraciones orales de GRT0151Y a diferentes dosis con las de placebo en pacientes con artrosis crónica de rodilla.
    E.2.2Secondary objectives of the trial
    - Evaluar la eficacia analgésica y la seguridad de múltiples administraciones orales de GRT0151Y a diferentes dosis en comparación con las de oxicodona CR en pacientes con artrosis crónica de rodilla.
    - Valorar la relación dosis respuesta de diferentes dosis de GRT0151Y en la administración de dosis múltiples en pacientes con dolor crónico.
    - Evaluar la farmacocinética y la farmacodinamia de poblaciones.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Hombres o mujeres no embarazadas ni en periodo de lactancia. Las mujeres potencialmente fértiles deberán utilizar un método anticonceptivo seguro (hormonales, DIU o de doble barrera) durante el estudio y deberán presentar una prueba de embarazo en orina negativa (en la visita de selección y en el día 1).
    - 40-70 años de edad.
    - Ausencia de anormalidades clínicamente significativas en los parámetros de laboratorio determinados en la visita de selección.
    - Pacientes con diagnóstico clínico de artrosis de rodilla en base a los criterios del ACR y capacidad funcional de clase I–III. Síntomas o criterios radiográficos presentes desde al menos 3 meses.
    - Antecedentes de dolor en la articulación diana durante > 6 meses, en tratamiento con analgésicos adecuados en al menos 60 de los últimos 90 días. Los pacientes que hayan utilizado opioides previamente deben haber presentado un beneficio terapéutico positivo con dichos
    - Aumento de la intensidad del dolor en la articulación diana de al menos un punto alcanzando un mínimo de 5 puntos después del periodo de lavado, mediante una NRS
    E.4Principal exclusion criteria
    - Evidencia o antecedentes de enfermedad psiquiátrica, personalidad neurótica, demencia senil severa, enfermedad de Alzheimer, antecedentes de crisis convulsivas, riesgo de suicidio, o traumatismo encefálico que requiera la evaluación por el personal del hospital. Los pacientes con depresión bien controlada pueden participar si tienen trastorno unipolar sin episodios maníacos en los antecedentes personales o familiares.
    - Mala situación médica (p. ej., clase ≥3 de la NYHA; clasificación de Child de la insuficiencia hepática >A (Pugh y cols., 1973); enfermedad pulmonar obstructiva crónica descompensada) o, a criterio del investigador, signos clínicos que planteen dudas sobre la idoneidad del paciente para el estudio.
    - Creatinina mayor de 1’5 x límite superior del intervalo normal.
    - ALT o AST mayores de 3 x límite superior del intervalo normal.
    - ECG en la visita de selección con hallazgos que pudieran influir sobre algún procedimiento previsto en el estudio: p. ej. una alteración notable de la repolarización (como sospecha o presencia de síndrome congénito de QT prolongado) y/o valores de QT de: QTCB en mujeres ≥ 450 ms, QTCB en hombres ≥ 430 ms, QT no corregido ≥ 500 ms-.
    - Signos clínicos agudos de dolor referido, dolor de origen en menisco o ligamentos y las siguientes causas patógenas: congénita, traumática directa, inducida por cristales, metabólica, infecciosa y autoinmunitaria. Diagnóstico clínico de fibromialgia según la definición del ACR.
    - Antecedentes de cirugía sustitutiva en la articulación diana, o se espera que el paciente precise intervención quirúrgica en la articulación diana
    - Administración intraarticular (articulación diana) de esteroides depot en los 3 meses previos o de suplementos viscosos en los 6 meses previos a la visita de selección.
    - Comienzo de fisioterapia y/o uso de dispositivos ortopédicos ≤ 4 semanas antes de la visita de selección.
    - Sospecha o alergia/hipersensibilidad conocidas a fármacos que tengan un mecanismo de acción similar al del producto en investigación. Contraindicación/hipersensibilidad conocida a opioides, oxicodona o paracetamol.
    - Uso de fentanilo en sistema transdérmico, o de buprenorfina sublingual o en sistema transdérmico, ≤ 7 días antes de la visita de selección.
    - Uso crónico oral (≥ 2 semanas) de corticosteroides menos de 2 semanas antes de la visita de selección.
    - Uso de antiparkinsonianos, inhibidores de la MAO, ISRS, IRSN, neurolépticos u otros fármacos que pueden reducir el umbral convulsivo ≤ 4 semanas antes de la visita de selección.
    - Uso de analgésicos adyuvantes (p. ej., antidepresivos tricíclicos, antiepilépticos, relajantes musculares) y de fármacos modificadores de la enfermedad (p. ej., glucosaminas) si no está con una dosis estable desde al menos 28 días antes de la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Intensidad de dolor media durante las 24 horas anteriores evaluada en la visita final mediante una escala de valoración numérica (NRS, numeric rating scale) de 11 puntos.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Tal y como se establece en el protocolo.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 460
    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 Decision2006-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
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