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    Summary
    EudraCT Number:2006-003482-14
    Sponsor's Protocol Code Number:KF5503/24-R331333-PAI-3007
    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:2012-03-15
    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 number2006-003482-14
    A.3Full title of the trial
    A One-Year, Randomized, Open-Label, Parallel-Arm, Phase III Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR* and Oxycodone CR in Subjects with Chronic Pain
    Estudio en Fase III de seguridad a largo plazo, aleatorizado, abierto, en grupos paralelos, con ajuste controlado de dosis, de un año de seguimiento sobre dosis múltiples de CG5503 LP* y Oxicodona LC en pacientes con dolor crónico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A One-Year, Randomized, Open-Label, Parallel-Arm, Long-Term Safety Trial, with Controlled Adjustment of Dose, of Multiple Doses of CG5503 Prolonged release and Oxycodone Controlled Release in Subjects with Chronic Pain
    A.4.1Sponsor's protocol code numberKF5503/24-R331333-PAI-3007
    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 Andrómaco, 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 supportLaboratorios Andromaco S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLaboratorios Andromaco S.A.
    B.5.2Functional name of contact pointGerente de Registros
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Zamenhof 36
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913019300
    B.5.5Fax number+34913019304
    B.5.6E-mailregulatory.es@grunenthal.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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.IMP: 3
    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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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.IMP: 4
    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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 5
    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 nameCG5503; R331333
    D.3.2Product code CG5503; R331333
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTapentadol
    D.3.9.1CAS number 175591-09-0
    D.3.9.3Other descriptive name(-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 6
    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 OxyContin® recubierto, comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmceuticals 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®
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOxycodone
    D.3.9.2Current sponsor coden. a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 7
    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 OxyContin® recubierto, comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmceuticals 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®
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOxycodone
    D.3.9.2Current sponsor coden. a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 8
    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 OxyContin® recubierto, comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmceuticals 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®
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNOxycodone
    D.3.9.2Current sponsor coden. a.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic pain due to knee or hip osteoarthritis or low back pain
    Dolor crónico debido a artrosis de rodilla o cadera o lumbalgia
    E.1.1.1Medical condition in easily understood language
    Chronic pain due to knee or hip osteoarthritis or low back pain
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049475
    E.1.2Term Chronic pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial will be evaluation of the safety profile of CG5503 PR base at doses 100 mg - 250 mg BID over long-term exposure of up to one year
    El objetivo principal del presente ensayo clínico es la evaluación del perfil de seguridad de CG5503 LP en dosis (base) de 100 mg a 250 mg dos veces al día tras una exposición a largo plazo de hasta un año de duración.
    E.2.2Secondary objectives of the trial
    Assessment of CG5503 PR and oxycodone CR dose requirements during long-term exposure.
    Evaluation of symptoms related to constipation using the Patient?s Assessment of Constipation Symptoms (PAC-SYM).
    Evaluate sleep quality by using Sleep Questionnaire (SQ).
    Evaluation for symptoms of withdrawal following discontinuation of treatment using both the Clinical Opiate Withdrawal Scale (COWS) and, in the US, the Subjective Opiate Withdrawal Scale (SOWS) questionnaires.
    Assessment of efficacy over the one-year trial period, based on pain intensity scores using an 11-point Numerical Rating Scale (NRS).
    Assessment of efficacy based on the subject?s and Investigator?s global assessment of the IMP.
    Assessment of efficacy based on Patient?s Global Impression of Change (PGIC) using a 7-point verbal rating scale.
    Assessment of quality of life based on EuroQol-5 Dimension (EQ-5D).
    Assessment of quality of life based on Short Form-36 Health Survey (SF-36®).
    ?Requerimientos de CG5503 LP y de oxicodona durante la exposición a largo plazo
    ?Síntomas relacionados con el estreñimiento (Cuestionario de Valoración de los Síntomas de Estreñimiento por parte del Paciente (PAC-SYM).)
    ?Calidad del sueño (Cuestionario del Sueño (CS)).
    ?Síntomas de retirada tras la interrupción del tratamiento (Escala Clínica de Dependencia tras la Retirada de Opioides (COWS) y Escala Subjetiva de Dependencia tras la Retirada de Opioides (SOWS)).
    ?Eficacia durante el periodo de seguimiento de un año mediante una Escala Numérica de Puntuación de 11 puntos (NRS).
    ?Eficacia en función de la valoración global del PME por el paciente y el investigador.
    ?Eficacia mediante la Escala de Impresión Global de Cambio por el Paciente (IGCP) mediante una escala verbal de 7 categorías.
    ?Calidad de vida (EuroQol-5 Dimensiones (EQ-5D)).
    ?Calidad de vida (SF-36 (SF-36®)).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes varones o mujeres no embarazadas ni en periodo de lactancia. Las mujeres que mantengan una vida sexual activa deben ser bien posmenopáusicas, bien estériles quirúrgicamente, bien seguir un método anticonceptivo eficaz (tal como anticonceptivos orales bajo control médico, inyecciones anticonceptivas, dispositivos intrauterinos, procedimientos de doble barrera, esterilización del miembro masculino de la pareja) antes y durante el estudio. En el momento de la selección todas las mujeres deberán presentar una prueba de embarazo basada en ß-hCG en suero negativa.
    2. Pacientes con edades iguales o superiores a 18 años.
    3. Pacientes que no estén satisfechos con su tratamiento analgésico actual (como AINEs, iCOX-2, opioides, paracetamol).
    4. Pacientes que presenten una intensidad de dolor >4 en la NRS en el momento basal tras el periodo de lavado.
    5. Pacientes con un diagnóstico clínico de artrosis de rodilla o cadera con antecedentes de dolor en la articulación de referencia al menos durante los últimos 3 meses o con diagnóstico clínico de lumbalgia no maligna con al menos 3 meses de evolución.
    6. Pacientes que otorguen su consentimiento informado que atestigüe su correcta comprensión de los propósitos y los procedimientos del estudio y que desean participar voluntariamente en el mismo.
    E.4Principal exclusion criteria
    Generales:
    1. Pacientes que estén participando en otro ensayo clínico de forma simultánea o durante los 30 días anteriores a la entrada en el estudio de CG5503.
    2. Pacientes que hayan participado previamente en este o en otros estudios de CG 5503.
    3. Pacientes con antecedentes de abuso de alcohol o drogas según el criterio del investigador, la historia clínica o la exploración física.
    4. Pacientes con incapacidad, conocida o sospechada, para cumplir el protocolo del estudio o utilizar la medicación del estudio.
    5. Pacientes con cirugía mayor programada o probable durante el periodo del estudio.
    6. Pacientes sometidos a intervenciones quirúrgicas en la articulación de referencia o en la columna lumbar en los 3 meses anteriores a la visita de selección.
    7. Pacientes con alguna relación laboral con el investigador o con el centro del estudio, que tengan relación directa con el presente estudio o con otros estudios que el investigador o el centro haya o esté llevando a cabo en la actualidad, o que sean parientes de personas con alguna relación laboral con el investigador.
    8. Pacientes que padezcan alguna enfermedad clínicamente relevante que, en opinión del investigador, pueda interferir con las evaluaciones de eficacia o de seguridad del estudio.

    Específicos del estudio:
    1. Antecedentes de trastornos convulsivos o epilepsia en cualquier momento de la vida; de lesiones cerebrales traumáticas leves/moderadas, ictus, accidente isquémico transitorio, o neoplasia cerebral en el último año; de lesiones cerebrales traumáticas severas en los 15 años anteriores (con uno o más de los siguientes criterios: contusión cerebral, hematoma intracraneal, pérdida de conciencia o amnesia postraumáticas durante más de 24 horas) o que presenten secuelas residuales que sugieran cambios transitorios del estado de conciencia.
    2. Pacientes con antecedentes de enfermedad maligna en los 2 años anteriores, a excepción de carcinoma basocelular tratado satisfactoriamente.
    3. Pacientes con hipertensión no controlada (presión arterial sistólica >160 mm Hg o presión arterial diastólica >95 mm Hg).
    4. Pacientes en tratamiento con medicaciones prohibidas (véase el apartado correspondiente a la medicación concomitante).
    5. Pacientes con resultados analíticos que sugieran función hepática inadecuada (ALT y/o AST por encima de 3 veces el límite superior de la normalidad).
    6. Pacientes con insuficiencia renal moderada o severa, según los criterios de definición que se utilicen en el país correspondiente.
    7. Pacientes con antecedentes de hipersensibilidad o alergia a oxicodona o paracetamol, o con contraindicación para estos fármacos.
    8. Pacientes que estén en litigio por incapacidad en la actualidad o lo hayan estado en el pasado.
    9. Pacientes con dolor importante causado por otros procesos diferentes a la artrosis o la lumbalgia que pudiese confundir las evaluaciones del dolor.
    E.5 End points
    E.5.1Primary end point(s)
    No formal statistical testing will be performed in this study.
    En el presente estudio no se realizarán contrastes estadísticos formales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA73
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Croatia
    Czech Republic
    France
    Germany
    Ireland
    Netherlands
    Portugal
    Slovakia
    Slovenia
    Spain
    United Kingdom
    United States
    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 for the last patient
    última visita del último paciente
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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.1.2.1Number of subjects for this age range: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 1075
    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)
    Clinical practice
    Practica clinica
    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 Decision2007-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-28
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