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    Summary
    EudraCT Number:2012-002943-11
    Sponsor's Protocol Code Number:KF5503/60
    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:2013-04-09
    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 number2012-002943-11
    A.3Full title of the trial
    Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus oxycodone/naloxone PR in non-opioid pre-treated subjects with uncontrolled severe chronic low back pain with a neuropathic pain component.
    Evaluación de la efectividad, la seguridad y la tolerabilidad de tapentadol LP en comparación con oxicodona/naloxona LP en sujetos con lumbalgia crónica intensa no controlada con un componente de dolor neuropático no tratados previamente con opioides
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of tapentadol PR and oxycodone/naloxone PR
    Tapentadol LP en comparación con oxicodona/naloxona LP
    A.4.1Sponsor's protocol code numberKF5503/60
    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 SponsorGrünenthal GmbH
    B.1.3.4CountryGermany
    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 supportGrünenthal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGRT Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.3.4CountryGermany
    B.5.4Telephone number+492415693223
    B.5.6E-mailClinical-Trials@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 Yes
    D.2.1.1.1Trade name Palexia retard 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 hydrochloride
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive nameTAPENTADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB32145
    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 Yes
    D.2.1.1.1Trade name Palexia retard 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 hydrochloride
    D.3.9.1CAS number 175591-09-0
    D.3.9.2Current sponsor codeCG5503
    D.3.9.3Other descriptive nameTAPENTADOL HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB32145
    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 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 Targin 10 mg / 5 mg Retard Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnaloxone hydrochloride dihydrate
    D.3.9.1CAS number 51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12168MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Targin 20 mg / 10 mg Retard tables
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnaloxone hydrochloride dihydrate
    D.3.9.1CAS number 51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12168MIG
    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: 5
    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 Targin 40 mg / 20 mg Retard tables
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnaloxone hydrochloride dihydrate
    D.3.9.1CAS number 51481-60-8
    D.3.9.3Other descriptive nameNALOXONE HYDROCHLORIDE DIHYDRATE
    D.3.9.4EV Substance CodeSUB12168MIG
    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: 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 Oxygesic 10 mg Retard tables
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 hydrochloride
    D.3.9.1CAS number 124-90-3
    D.3.9.3Other descriptive nameOXYCODONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03583MIG
    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.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
    Severe chronic low back pain with a neuropathic pain component
    Lumbalgia crónica intensa con un componente de dolor neuropático
    E.1.1.1Medical condition in easily understood language
    Severe chronic low back pain
    Lumbalgia crónica intensa
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024891
    E.1.2Term Low back pain
    E.1.2System Organ Class 100000004859
    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 is to evaluate the effectiveness, safety, and tolerability of tapentadol PR versus oxycodone/naloxone PR in non-opioid pre-treated subjects with uncontrolled severe chronic low back pain with a neuropathic pain component.
    El objetivo principal consiste en evaluar la efectividad, la seguridad y la tolerabilidad de tapentadol LP en comparación con oxicodona/naloxona LP en sujetos con lumbalgia crónica intensa no controlada con un componente de dolor neuropático no tratados previamente con opioides.
    E.2.2Secondary objectives of the trial
    ? To evaluate and compare tolerability profiles of tapentadol PR versus oxycodone/naloxone PR during the titration period and throughout the trial with a focus on gastrointestinal and central nervous system-related tolerability.
    ? To evaluate the impact of tapentadol PR and oxycodone/naloxone PR on neuropathic pain-related symptoms.
    ? To compare the impact on function and quality of life parameters between tapentadol PR and oxycodone/naloxone PR in subjects with severe chronic low back pain.
    ? To compare effectiveness in terms of reduction of pain intensity between tapentadol PR and oxycodone/naloxone PR during titration as well as throughout the entire treatment period in the trial.
    ? To investigate the impact of tapentadol PR versus oxycodone/naloxone PR on serum levels of sexual hormones (e.g., luteinizing hormone [LH], follicle-stimulating hormone [FSH], and total testosterone) during the trial.
    ? Evaluar y comparar los perfiles de tolerabilidad de tapentadol LP en comparación con oxicodona/naloxona LP durante el período de ajuste de la dosis y durante el ensayo centrándose en la tolerabilidad relacionada con el aparato digestivo y el sistema nervioso central.
    ? Evaluar el efecto de tapentadol LP y de oxicodona/naloxona LP sobre los síntomas asociados a dolor neuropático.
    ? Comparar el efecto sobre parámetros de función y calidad de vida entre tapentadol LP y oxicodona/naloxona LP en sujetos con lumbalgia crónica intensa.
    ? Comparar la eficacia en términos de reducción de la intensidad del dolor entre tapentadol LP y oxicodona/naloxona LP durante el período de ajuste de la dosis, así como durante el período de tratamiento completo en el ensayo.
    ? Evaluar el efecto de tapentadol LP en comparación con oxicodona/naloxona LP sobre concentraciones séricas de hormonas sexuales (p. ej. lutropina [LH], folitropina [FSH] y testosterona total) durante el ensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent signed.
    2. Male or female subject ?18 years of age.
    3. Women of childbearing potential must have a negative pregnancy test at the Enrollment Visit.
    4. Women of childbearing potential must practice medically acceptable methods of birth control during the trial.
    5. Subjects must be appropriately communicative and able to differentiate with regard to location and intensity of the pain, and to complete the questionnaires used in this trial.
    6. Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months prior to enrollment.
    7. Subject?s pain must require a strong analgesic (defined as WHO Step III) as judged by the investigator.
    8. Subjects who require a washout of co-analgesics at enrollment must have an average pain score (NRS-3) of 5 points or higher.
    Subjects who do not require a washout of co-analgesics at enrollment must have an average pain intensity score (NRS-3) of 6 points or higher.
    9. The painDETECT diagnostic screening questionnaire must be either ?positive? (= score of 19 to 38 inclusive) or ?unclear? (= score of 13 to 18 inclusive) or If the subject is being treated with a stable regimen of centrally acting co-analgesics, a ?negative? painDETECT scorescore (but 9 points or higher) at the Enrollment Visit will be acceptable
    Inclusion criteria at the Randomization Visit
    10. Subjects must have an average pain intensity score (NRS-3) of 6 points or higher.
    11. Subjects must score either ?positive? (= score of 19 to 38 inclusive) or ?unclear? (= score of 13 to 18 inclusive) on the painDETECT diagnostic screening questionnaire.
    1. Firma del documento de consentimiento informado
    2. Hombre o mujer >=18 años de edad.
    3. Las mujeres fértiles deberán someterse a una prueba de embarazo con resultado negativo en la visita de inclusión.
    4. Las mujeres fértiles deberán adoptar métodos anticonceptivos médicamente aceptables durante el ensayo.
    5. Los sujetos deberán ser capaces de comunicarse adecuadamente, distinguir la localización y la intensidad del dolor y rellenar los cuestionarios que se utilizan en este ensayo.
    6. Los sujetos deberán tener un diagnóstico de lumbalgia crónica; por crónico se entiende un dolor que dura como mínimo 3 meses antes de la inclusión.
    7. El dolor que sufre el paciente debe exigir tratamiento con un analgésico potente (escalón III de la OMS) a criterio del investigador.
    8. Los sujetos que deban someterse a un período de lavado de coanalgésicos en la inclusión deberán tener una puntuación de la intensidad del dolor medio (NRS-3) de 5 puntos o más.
    Los sujetos que no tengan que someterse a un período de lavado de coanalgésicos en la inclusión deberán tener una puntuación de la intensidad del dolor medio (NRS-3) de 6 puntos o más.
    9. El resultado del cuestionario de diagnóstico PainDETECT debe ser "positivo" (= puntuación de 19 a 38, ambos inclusive) o "dudoso" (= puntuación de 13 a 18, ambos inclusive) o Si el sujeto está siendo tratado con una pauta estable de coanalgésicos con actividad sobre el sistema nervioso central se aceptará una puntuación "negativa" en painDETECT (de 9 puntos o superior) en la visita de inclusión.
    10. Los sujetos deben registrar una puntuación de la intensidad del dolor medio (NRS-3) de 6 puntos o más.
    11. Los sujetos deben registrar un resultado "positivo" (= puntuación de 19 a 38, ambos inclusive) o "dudoso" (= puntuación de 13 a 18, ambos inclusive) en el cuestionario de diagnóstico PainDETECT.
    E.4Principal exclusion criteria
    1. Presence of a clinically significant disease or clinical laboratory values that in the investigator?s opinion may affect effectiveness, quality of life, or safety/tolerability assessments
    2. Presences of active systemic or local infections that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety/tolerability assessments.
    3. Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members of employees of the investigator.
    4. Participation in another trial concurrently, or within 4 weeks prior to the Enrollment Visit.
    5. Known to or suspected of not being able to comply with the protocol and/or appropriate use of the IMPs.
    6. Any painful procedures (e.g., major surgery) scheduled during the trial duration (Enrollment Visit until Final Evaluation Visit) that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety assessments.
    7. Pending litigation or application for insurance/governmental benefits due to chronic pain or disability and/or if the granted benefits might be influenced by a successful participation in the trial.
    8. Low back pain caused by cancer and/or metastatic diseases.
    9. History of alcohol or drug abuse, or suspicion thereof in the investigator?s judgment.
    10. Presence of concomitant autoimmune inflammatory conditions.
    11. Subjects with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic active substances.
    12. Subjects with severe renal impairment, i.e., estimated glomerular filtration rate less than 30 mL/min (according to the National Kidney Foundation 2002).
    13. Known history of clinical laboratory values or current clinical laboratory values reflecting moderately or severely impaired hepatic function.
    14. History of seizure disorder or epilepsy.
    15. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm (including brain metastases if present at the Enrollment Visit). Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 hours) or residual sequelae.
    16. Pregnant or breast-feeding women.
    17. Severe respiratory depression with hypoxia and/or hypercapnia, acute or severe bronchial asthma or severe chronic obstructive pulmonary disease.
    18. Presence or suspicion of paralytic ileus.
    19. Subjects with severe cardiac impairment, e.g., New York Heart Association class >3, myocardial infarction less than 6 months prior to the Enrollment Visit, and/or unstable angina pectoris and/or cor pulmonale.
    20. Subjects with known history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
    21. History of allergy or hypersensitivity to tapentadol, oxycodone, naloxone, and their formulations.
    22. Subjects with acute biliary obstruction or acute pancreatitis.
    23. Subjects with hypothyroidism (including myxedema) or Addison?s disease.
    24. Subjects taking any prohibited concomitant medication.
    1. Presencia de una enfermedad de trascendencia clínica o resultados de pruebas analíticas que, en opinión del investigador, puedan afectar a las evaluaciones de la eficacia, la calidad de vida o la seguridad/tolerabilidad.
    2. Presencia de infecciones activas sistémicas o locales que puedan, en opinión del investigador, afectar a las evaluaciones de la efectividad, la calidad de vida o la seguridad/tolerabilidad.
    3. Empleados del investigador o del centro del ensayo que participen directamente en este ensayo o en otros ensayos bajo la dirección del investigador o del centro del ensayo, así como los familiares de los empleados del investigador.
    4. Participación en otro ensayo clínico simultáneo, o en las 4 semanas anteriores a la visita de inclusión.
    5. Sujetos que se sepa o se sospeche que no podrán cumplir con el protocolo y/o realizar un uso adecuado de los MI.
    6. Cualquier procedimiento doloroso (p. ej. cirugía mayor) programado durante la realización del ensayo (desde la visita de inclusión hasta la visita de evaluación final) que pudiera, en opinión del investigador, afectar a las evaluaciones de la efectividad, la calidad de vida o la seguridad.
    7. Litigio o solicitud pendiente de prestaciones públicas/de seguro debido a dolor crónico o discapacidad y/o si las prestaciones concedidas pudieran verse afectadas por una participación satisfactoria en el ensayo.
    8. Lumbalgia provocada por cáncer y/o enfermedades metastásicas.
    9. Antecedentes de alcoholismo o drogadicción, o sospecha de cualquiera de ellos por parte del investigador.
    10. Presencia de enfermedades inflamatorias autoinmunitarias concomitantes.
    11. Pacientes con intoxicación aguda provocada por alcohol, somníferos, analgésicos con actividad sobre el sistema nervioso central o psicofármacos.
    12. Sujetos con insuficiencia renal grave, es decir, filtración glomerular estimada inferior a 30 ml/min (con arreglo a la National Kidney Foundation 2002).
    13. Antecedentes confirmados de valores de pruebas analíticas o valores de pruebas analíticas actuales que indiquen una disfunción hepática moderada o grave.
    14. Antecedentes de convulsiones o epilepsia.
    15. Cualquiera de los siguientes acontecimientos en el año anterior: lesión cerebral traumática leve/moderada, accidente cerebrovascular, accidente isquémico transitorio o neoplasia cerebral (incluida metástasis cerebral si está presente en la visita de inclusión). Lesión cerebral traumática grave en los 15 años anteriores (consistente en 1 o más de los siguientes acontecimientos: contusión cerebral, hematoma intracraneal, inconsciencia o amnesia postraumática con una duración superior a 24 horas) o secuelas que indiquen cambios transitorios en la consciencia.
    16. Mujeres embarazadas o en período de lactancia.
    17. Depresión respiratoria grave con hipoxia y/o hipercapnia, asma bronquial agudo o grave o enfermedad pulmonar obstructiva crónica grave.
    18. Presencia o sospecha de íleo paralítico.
    19. Sujetos con insuficiencia cardíaca grave, por ejemplo, infarto de miocardio de clase >3 según la clasificación de la New York Heart Association menos de 6 meses antes de la visita de inclusión y/o angina de pecho inestable y/o cardiopatía pulmonar.
    20. Sujetos con antecedentes confirmados de problemas hereditarios raros de intolerancia a la galactosa, intolerancia a la lactosa o intolerancia a la glucosa-galactosa.
    21. Antecedentes de alergia o hipersensibilidad a tapentadol, oxicodona, naloxona y sus formulaciones.
    22. Sujetos con obstrucción biliar aguda o pancreatitis aguda.
    23. Sujetos que padecen hipotiroidismo (incluido mixedema) o enfermedad de Addison.
    24. Sujetos que toman cualquiera de los medicamentos concomitantes prohibidos.
    E.5 End points
    E.5.1Primary end point(s)
    The first primary endpoint of this trial is defined as the change in the average pain intensity core during the last 3 days (numerical rating scale [NRS]-3 pain intensity scores) from the Randomization Visit to the end of continuation (Final Evaluation Visit, 12 weeks after the Randomization Visit).
    The second primary endpoint will be the change in the patient assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the end of continuation (Final Evaluation Visit, 12 weeks after the Randomization Visit).
    El primer criterio principal de valoración de este ensayo se define como la variación registrada en la puntuación de la intensidad del dolor medio durante los 3 últimos días (puntuaciones de la intensidad del dolor en la escala de valoración numérica [NRS]- 3) desde la visita de aleatorización hasta el final del período de mantenimiento (visita de evaluación final, 12 semanas después de la visita de aleatorización).
    El segundo criterio principal de valoración será la variación registrada en la puntuación total del cuestionario de evaluación de síntomas de estreñimiento (PAC-SYM) del paciente desde la visita de aleatorización hasta el final del período de mantenimiento (visita de evaluación final, 12 semanas después de la visita de aleatorización).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final evaluation visit
    Visita de evaluación final
    E.5.2Secondary end point(s)
    1.Comparison of relevant parameters related to the evaluation of early gastrointestinal treatment emergent adverse events (TEAEs) under tapentadol PR and oxycodone/naloxone PR.
    2.
    ? Pain intensity scores on an 11-point NRS-3.
    ? PainDETECT scores.
    ? EuroQol-5 Dimension (EQ-5D) scores.
    ? NRS-3 pain intensity scores for pain radiating towards or into the leg.
    ? Worst pain (11-point NRS) during the last 24 hours prior to the assessment visit.
    ? Patient global impression of change (PGIC).
    ? Clinician?s global impression of change (CGIC).
    ? Neuropathic pain symptom inventory (NPSI).
    ? Short Form-12® health survey (SF-12) scores.
    ? Hospital anxiety and depression scale (HADS).
    ? Sleep evaluation score.
    ? Work productivity and activity impairment questionnaire (WPAI).
    ? Adverse events
    ? Overall discontinuation rates related to treatment arms
    ? Time to discontinuation from treatment (due to any reason).
    ? Time to discontinuation from treatment (due to adverse events).
    ? PAC-SYM.
    ? Vital signs.
    ? Clinical laboratory values.
    ? Medication used to treat the adverse events related to the IMPs.
    ? Hormone serum levels under treatment with IMPs:
    ? Aging males? symptoms questionnaire
    1. Comparación de parámetros pertinentes relacionados con la evaluación de acontecimientos adversos surgidos durante el tratamiento (AADT) tempranos relacionados con el aparato digestivo en el grupo tratado con tapentadol LP y oxicodona/naloxona LP
    2.
    ? Puntuaciones de intensidad del dolor en una escala NRS-3 de 11 puntos.
    ? Puntuaciones de PainDETECT.
    ? Puntuaciones de EuroQol-5 Dimension (EQ-5D).
    ? Puntuaciones de la intensidad del dolor obtenidas en NRS-3 para dolor radiante hacia la pierna o en la pierna.
    ? Peor dolor (NRS de 11 puntos) durante las 24 horas anteriores a la visita de evaluación.
    ? Impresión global del cambio percibida por el paciente (IGCP).
    ? Impresión global del cambio percibida por el médico (IGCM).
    ? Escala de evaluación de síntomas específicos del dolor neuropático (NPSI).
    ? Puntuaciones obtenidas en el cuestionario sobre el estado de salud Short Form-12® (SF-12).
    ? Escala de ansiedad y depresión hospitalaria (HADS).
    ? Puntuación obtenida en la evaluación del sueño.
    ? Cuestionario de alteración de la actividad y productividad laboral (WPAI).
    ? Acontecimientos adversos.
    ? Tasas totales de interrupción de la administración en relación con los grupos de tratamiento.
    ? Tiempo hasta la interrupción del tratamiento (por cualquier motivo).
    ? Tiempo hasta la interrupción del tratamiento (debido a acontecimientos adversos).
    ? PAC-SYM.
    ? Constantes vitales.
    ? Valores de pruebas analíticas.
    ? Medicación administrada para tratar los acontecimientos adversos relacionados con los MI.
    ? Concentraciones séricas de las siguientes hormonas durante el tratamiento con los MI.
    ? Cuestionario de síntomas para varones de edad avanzada
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At respective site visits during the early treatment phase
    2. At respective site visits as specified in the protocol
    1. En las respectivas visitas al centro durante la fase inicial del tratamiento
    2. En las respectivas visitas al centro como se especifican en el protocolo
    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 Yes
    E.6.13.1Other scope of the trial description
    effectiveness and tolerability
    efectividad y tolerabilidad
    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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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
    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 Decision2013-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-05
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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