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    Summary
    EudraCT Number:2012-001920-36
    Sponsor's Protocol Code Number:KF6005/06
    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:2012-10-15
    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 number2012-001920-36
    A.3Full title of the trial
    Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain
    Eficacia, seguridad y tolerabilidad de GRT6005 en pacientes con dolor lumbar crónico de moderado a severo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain
    Eficacia, seguridad y tolerabilidad de GRT6005 en pacientes con dolor lumbar crónico de moderado a severo
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberKF6005/06
    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 SponsorGrunenthal 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 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 nameGRT6005 100 µg film-coated tablet
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Film-coated 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 INNGRT6005
    D.3.9.2Current sponsor codeGRT6005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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: 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 nameGRT6005 200 µg film-coated tablet
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Film-coated 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 INNGRT6005
    D.3.9.2Current sponsor codeGRT6005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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: 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 nameGRT6005 400 µg film-coated tablet
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Film-coated 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 INNGRT6005
    D.3.9.2Current sponsor codeGRT6005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Palexia® retard 50 mg
    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 nameTapentadol 50 mg PR2 tablet
    D.3.2Product code CG5503
    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: 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 Palexia® retard 100 mg
    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 nameTapentadol 100 mg PR2 tablet
    D.3.2Product code CG5503
    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: 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 Palexia® retard 150 mg
    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 nameTapentadol 150 mg PR2 tablet
    D.3.2Product code CG5503
    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 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: 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 Palexia® retard 200 mg
    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 nameTapentadol 200 mg PR2 tablet
    D.3.2Product code CG5503
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release film-coated tablet
    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
    moderate to severe chronic low back pain
    dolor lumbar crónico de moderado a severo
    E.1.1.1Medical condition in easily understood language
    moderate to severe chronic low back pain
    dolor lumbar crónico de moderado a severo
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    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 objective of this trial is to assess the analgesic efficacy, safety, and tolerability of once daily
    orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 ?g, 400 ?g, and 600 ?g GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.
    Evaluar la eficacia analgésica, la seguridad y la tolerabilidad de la administración oral una vez al día de GRT6005 utilizando 3 dosis fijas (es decir, 200 µg, 400 µg y 600 µg de GRT6005), en comparación con placebo, en pacientes con DL crónico de moderado a severo.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Male or female subject 18 years to 80 years of age at Visit 1.
    ? Documented clinical diagnosis of chronic LBP of non-malignant origin and pain present for at least 3 months.
    ? Average 24 hour pain ?5 on an 11 point NRS during the 3 days prior to Visit 3 without the use of rescue medication. Subjects must have 3 out of three 24 hour pain assessments during this 3 day period.
    ? Subjects must be on stable analgesic medications (non-opioid and/or opioid medications) for their chronic LBP with regular intake (i.e., at least 4 days per week) for at least 3 months prior to Visit 1 according to their medical history and dissatisfied with current analgesic treatment.
    ? Subjects requiring opioid treatment must be taking daily doses of opioid-based analgesic equivalent to ?160 mg of oral morphine.
    . Consentimiento informado firmado.
    . Hombres o mujeres que tengan entre 18 y 80 años de edad en el momento de la visita 1.
    . Las mujeres en edad fértil deben tener una prueba de embarazo de gonadotropina coriónica humana ? (?-hCG) en orina negativa en las visitas 1 y 3.
    . Los pacientes deben estar utilizando métodos anticonceptivos altamente eficaces y clínicamente aceptables.
    . Los pacientes deberán ser capaces de comunicarse adecuadamente, de diferenciar la localización y la intensidad del dolor y de completar los cuestionarios utilizados en este ensayo clínico.
    . Diagnóstico clínico documentado de DL crónico de origen no neoplásico y presencia de dolor durante al menos 3 meses.
    . Dolor medio de 24 horas ?5 en una ECN de 11 puntos durante los 3 días previos a la visita 3, sin utilizar medicación de rescate. Los pacientes deberán completar las tres evaluaciones de dolor de 24 horas durante este periodo de 3 días.
    . Los pacientes deben estar recibiendo de forma estable medicación analgésica (opioide y/o no opioide) para su DL crónico, con una administración regular (es decir, al menos 4 días por semana) durante al menos 3 meses antes de la visita 1 de acuerdo con su historial clínico, y no estar satisfechos con su tratamiento analgésico actual.
    . Los pacientes que necesiten tratamiento opioide deberán estar tomando dosis diarias de analgésicos derivados de opioides equivalentes a ?160 mg de morfina oral.
    E.4Principal exclusion criteria
    ? Female subjects who are pregnant or are breastfeeding.
    ? Any clinically significant disease or laboratory findings that in the investigator's opinion may affect efficacy or safety assessments or may compromise the subject?s safety during trial participation
    ? Subjects with impaired hepatic functionality/cellular integrity
    ? History of acute hepatitis within 3 months of Visit 1 or chronic hepatitis or a positive result on anti-hepatitis A antibody, hepatitis B surface antigen, or anti?hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
    ? Subjects with impaired renal function.
    ? History of any major gastrointestinal prior procedures or gastrointestinal conditions that might affect the absorption or metabolism of GRT6005.
    ? Presence of risk factors for Torsade de Pointes
    ? Prolongation of QTc >450 ms at Visit 1 or at Visit 3.
    ? History of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy
    ? History or presence of malignancy, with the exception of curative treated subjects or subjects being in remission of cancer for at least 2 years and not requiring treatment.
    ? Subjects with chronic LBP potentially associated with a specific spinal cause
    ? Subjects with >1 previous low back surgeries or recent low-back surgery (within the last 12 months) or scheduled low back surgery during the trial or any other scheduled surgery or painful procedure during the course of the trial that, in the opinion of the investigator, may affect efficacy or safety assessments.
    ? Any invasive procedures (e.g., epidural injections like facet block injection or sacroileac joint block injection) within the past 3 months.
    ? Subjects with any kind of neuromodulation
    ? Clinically relevant history of hypersensitivity, allergy or contraindications to any of the IMPs? excipients, paracetamol/acetaminophen, tapentadol HCl, or opioid analgesics (or excipients).
    ? Presence of conditions other than LBP that could confound the assessment or self-evaluation of pain.
    ? Increased intracranial pressure, caused e.g., by severe traumatic brain injury or ischemic brain injury.
    ? Subjects with significant respiratory depression, with acute or severe bronchial asthma or hypercapnia, and suspected or diagnosed sleep apnea.
    ? Presence or suspicion of paralytic ileus.
    . Participación en otro ensayo clínico al mismo tiempo o en los 30 días previos a la visita 1 de este ensayo clínico.
    . Participación previa en este o en otro ensayo clínico con GRT6005
    . Abuso de alcohol o drogas o dependencia de opioides, actual o previa, a juicio del investigador, en función del historial del paciente, la exploración física o el resultado de la prueba de drogas en las visitas 1 o 3.
    . Mujeres embarazadas o en periodo de lactancia.
    . Conocimiento o sospecha de incapacidad para cumplir el protocolo y utilizar el FI o la medicación de rescate.
    . Cualquier enfermedad clínicamente significativa o hallazgos de laboratorio que, en opinión del investigador, pudiesen afectar a las valoraciones de eficacia o seguridad o comprometer la seguridad del paciente durante su participación en el ensayo clínico
    . Empleados del investigador, del centro de estudio o del promotor, con participación directa en el ensayo clínico propuesto o en otros ensayos clínicos bajo la dirección del mismo investigador, centro de estudio o promotor, así como familiares de dichos empleados o del investigador.
    . Pacientes con alteración de la integridad celular/funcionalidad hepática.
    . Historial de hepatitis aguda en los 3 meses previos a la visita 1 o hepatitis crónica o un resultado positivo en los análisis de anticuerpos anti-hepatitis A, antígeno de superficie de la hepatitis B o anticuerpos anti?hepatitis C. Historial de infección por el virus de la inmunodeficiencia humana (VIH).
    . Pacientes con alteración de la función renal.
    . Historial de cualquier cirugía mayor gastrointestinal previa o problemas gastrointestinales que pudiesen afectar a la absorción o el metabolismo de GRT6005.
    . Presencia de factores de riesgo de torsade de pointes. Prolongación del intervalo QTc >450 mseg en las visitas 1 o 3.
    . Historial de crisis y/o epilepsia, o cualquier enfermedad asociada a un riesgo importante de crisis o epilepsia, determinado en la visita 1 a juicio del investigador.
    . Historial o presencia de neoplasias malignas, a excepción de los pacientes curados por el tratamiento o aquellos en remisión del cáncer durante al menos 2 años y que no requieran tratamiento.
    . Pacientes con DL crónico potencialmente asociado a una causa medular específica.
    . Pacientes con >1 cirugía lumbar previa, cirugía lumbar reciente (en los últimos 12 meses), cirugía lumbar programada durante el ensayo clínico o programación de cualquier otra cirugía o procedimiento doloroso durante el ensayo clínico que, en opinión del investigador, pudiese afectar a las valoraciones de eficacia o seguridad.
    . Cualquier procedimiento invasivo (p. ej., inyecciones epidurales, como inyecciones de bloqueo de las articulaciones facetarias o sacroilíacas) en los últimos 3 meses.
    . Pacientes con cualquier tipo de neuromodulación.
    . Historial clínicamente relevante de hipersensibilidad, alergia o contraindicaciones para cualquiera de los excipientes del FI, paracetamol, tapentadol HCl o analgésicos opioides (o sus excipientes).
    . Presencia de enfermedades diferentes al DL que pudiesen falsear la evaluación o la autovaloración del dolor.
    Pacientes con IMC ?18 kg/m2 y ?35 kg/m2.
    . Pacientes pendientes de litigios o que hayan solicitado prestaciones a aseguradoras/organismos gubernamentales debido a su discapacidad o dolor crónico y, en caso de concederse, prestaciones que pudieran verse afectadas por la participación en el ensayo clínico.
    . Aumento de la presión intracraneal, causado p. ej., por una lesión cerebral traumática grave o una lesión cerebral isquémica.
    . Pacientes con depresión respiratoria significativa, con hipercapnia o asma bronquial agudo o grave, y con sospecha o diagnóstico de apnea del sueño.
    . Presencia o sospecha de íleo paralítico.
    . Uso de la medicación prohibida
    . Raros problemas hereditarios de intolerancia a la galactosa, deficiencia de lactasa de Lapp o malabsorción de glucosa-galactosa, intolerancia a la lactosa.
    . Enfermedades que requieran tratamiento con medicamentos prohibidos.
    . Pacientes con una puntuación painDETECT ?19 (válido solo después de que se alcance el número máximo de pacientes en el subgrupo painDETECT «positivo»).
    E.5 End points
    E.5.1Primary end point(s)
    In support of a marketing authorization in the European Union and other non-US countries worldwide, the primary endpoint will be the change from baseline pain to the weekly average 24 hour pain during the entire 12 weeks of the maintenance phase of the double-blind Treatment Period. The 24 hour pain will be assessed once daily using an 11 point numeric rating scale (NRS) and a 24 hour recall period.
    For the US regulatory authority, the primary endpoint will be the change from baseline pain to the average 24 hour pain during Week 12 of the maintenance phase. The 24 hour pain will be assessed once daily using an 11 point NRS and a 24 hour recall period.
    Cambio respecto al inicio del estudio en la media semanal del dolor de 24 horas, durante las 12 semanas de la fase de mantenimiento dentro del periodo de tratamiento doble ciego. El dolor de 24 horas se evaluará una vez al día utilizando una escala de calificación numérica (ECN) de 11 puntos y abarcando un periodo de 24 horas.
    Para EE. UU., el principal criterio de valoración será el cambio respecto al inicio del estudio en el promedio del dolor de 24 horas durante las 12 semanas de la fase de mantenimiento. El dolor de 24 horas se evaluará una vez al día utilizando una ECN de 11 puntos y abarcando un periodo de 24 horas
    E.5.1.1Timepoint(s) of evaluation of this end point
    entire 12 weeks of the maintenance phase of the double-blind Treatment Period (for EU and other non-US countries worldwide); Week 12 of the maintenance phase (for US regulatory authority)
    12 semanas de fase de mantenimiento doble ciego (en Europa y otros paises sin incluir EEUU); La semana 12 de la fase de mantenimiento (para las autoridades de EEUU)
    E.5.2Secondary end point(s)
    n.a.
    E.5.2.1Timepoint(s) of evaluation of this end point
    n.a.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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.8.2.4Number of treatment arms in the trial5
    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 EEA80
    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 years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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: 480
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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)
    Subjects will return to appropriate pain treatment after end of participation in the trial.
    los pacientes continuarán con un tratamiento analgésico adecuado.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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