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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-001903-10
    Sponsor's Protocol Code Number:OX51-002
    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:2012-08-07
    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 number2011-001903-10
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, dose finding trial using sublingual alfentanil to alleviate pain associated with a prostate biopsy procedure
    Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis de alfentanilo sublingual para el alivio del dolor asociado a una biopsia de próstata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn about the effect of alfentanil for pain relief in patients undergoing prostate biopsy
    A.4.1Sponsor's protocol code numberOX51-002
    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 SponsorOrexo AB
    B.1.3.4CountrySweden
    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 supportOrexo AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrexo AB
    B.5.2Functional name of contact pointDirector, Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressVirdings allé 32A
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75105
    B.5.3.4CountrySweden
    B.5.4Telephone number+46187808907
    B.5.5Fax number+46187808888
    B.5.6E-mailmarie.gardmark@orexo.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 nameOX51-3
    D.3.2Product code OX51-3
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALFENTANIL HYDROCHLORIDE
    D.3.9.1CAS number 69049-06-5
    D.3.9.4EV Substance CodeSUB00339MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number350
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALFENTANIL HYDROCHLORIDE
    D.3.9.1CAS number 69049-06-5
    D.3.9.4EV Substance CodeSUB00339MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pain associated with prostate biopsy.
    Dolor asociado a una biopsia de próstata
    E.1.1.1Medical condition in easily understood language
    Pain associated with prostate biopsy.
    Dolor asociado a una biopsia de próstata
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10004857
    E.1.2Term Biopsy prostate
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the analgesic efficacy of sublingual alfentanil tablets in patients who undergo prostate biopsy
    Evaluar la eficacia analgésica de los comprimidos sublinguales de alfentanilo en pacientes sometidos a una biopsia de próstata.
    E.2.2Secondary objectives of the trial
    1.To evaluate the safety and tolerability of sublingual alfentanil tablets.
    2.To evaluate the patients' sedation after administration of sublingual alfentanil tablets.
    3.To evaluate the relationship between dose and analgesic efficacy of sublingual alfentanil tablets in patients who undergo prostate biopsy.
    4.To evaluate the post-procedural pain.
    5.To evaluate the patients' and clinicians' satisfaction with the pain treatment of the procedure.
    6.To evaluate the need for rescue medication.
    7.To evaluate the PK profile of the sublingual alfentanil tablets in the target patient population.
    8.To evaluate the post-procedural recovery time.
    1.Evaluar la seguridad y tolerabilidad de los comprimidos sublinguales de alfentanilo.
    2.Evaluar la sedación de los pacientes después de la administración de los comprimidos sublinguales de alfentanilo.
    3.Evaluar la relación entre la dosis y la eficacia analgésica de los comprimidos sublinguales de alfentanilo en pacientes sometidos a una biopsia de próstata.
    4.Evaluar el dolor posterior al procedimiento.
    5.Evaluar el grado de satisfacción de los pacientes y el médico con el tratamiento del dolor durante el procedimiento.
    6.Evaluar la necesidad de medicación de rescate.
    7.Evaluar el perfil FC de los comprimidos sublinguales de alfentanilo en la población diana de pacientes.
    8.Evaluar el tiempo de recuperación posterior al procedimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men 18 to 85 years of age at the time of eligibility at Visit 1.
    2. Signed informed consent obtained.
    3. Abnormal digital rectal examination and/or elevated total prostate-specific antigen (tPSA) value > 4.0 ng/mL or increased Prostate-Specific Antigen (PSA) velocity based on Investigator judgment for biopsy.
    4. Body mass index (BMI) between 19.0 and 34.0 kg/m2 inclusive.
    1.Varones de 18 a 85 años de edad en el momento de la elegibilidad en la Visita 1.
    2.Obtención del consentimiento informado con la firma del paciente.
    3.Exploración rectal digital anormal y/o valor elevado del antígeno prostático específico total (tPSA) > 4,0 ng/ml o aumento de la velocidad del antígeno prostático específico (PSA) basado en el criterio del investigador para la biopsia.
    4.Índice de masa corporal (IMC) entre 19,0 y 34,0 kg/m2, ambos inclusive.
    E.4Principal exclusion criteria
    1. Previous prostate biopsy.
    2. Prior radiation therapy to pelvis.
    3. Anal fissure, anal stricture or any other anorectal pathology that may interfere with the prostate biopsy procedure, as judged by the Investigator.
    4. Suspected urinary tract infection or recent (within 30 days) active urological infection (e.g., prostatitis).
    5. Any known hypersensitivity or contraindication to alfentanil, other opioids or local anaesthetics.
    6. A history or presence of drug or alcohol abuse.
    7. Concomitant or prior use of opioids within 2 weeks prior to IMP administration.
    8. Concomitant or prior use of any analgesic treatment for pain within 24 hours prior to IMP administration.
    9. Concomitant or prior use of any sedating medications (e.g. barbiturates, benzodiazepines, neuroleptics, antihistamines) within 24 hours prior to IMP administration.
    10. Concomitant use of monoamine oxidase inhibitors (e.g. Aurorix/moklobemid).
    11. Concomitant or prior use of medium to strong cytochrome P450 (CYP) 3A4 enzyme inhibitors or 3A4 enzyme inducers within 14 days prior to IMP administration (pre-biopsy administration of antibiotics according to site standard practice is allowed, except for clarithromycin, erythromycin, telithromycin and rifampin/rifampicin. See Appendix 13.2 for prohibited medications).
    12. Bleeding diathesis.
    13. Anticoagulant treatment (aspirin up to max 160 mg/day is allowed).
    14. Chronic pain and/or need of chronic pain treatment.
    15. Current pain as measured by a score of > 3 on an 11-items Numerical Rating Scale (NRS).
    16. Severe airway and lung disease such as symptomatic asthma, chronic bronchitis, emphysema or sleep apnea syndrome.
    17. A history of any seizure disorder (other than febrile seizures).
    18. A history of significant liver or renal disease.
    19. A history of hypothyreosis.
    20. Clinically significant cardiac disease or central nervous system disease.
    21. Clinically significant abnormality detected in the patient?s physical examination, vital signs (including clinically significant abnormal orthostatic blood pressure) or 12-lead ECG as judged by the investigator.
    22. History and/or presence of any somatic disease/condition that may interfere with the objectives of the trial as judged by the Investigator.
    23. Participation in any other trial involving an IMP within 3 months before assessment of eligibility at Visit 1.
    24. Otherwise not suitable to participate in the trial in the opinion of the Investigator.
    1.Biopsia de próstata anterior.
    2.Radioterapia previa en la pelvis.
    3.Fisura anal, estenosis anal o cualquier otra patología anorrectal que pueda interferir con el procedimiento de biopsia de próstata, según el criterio del investigador.
    4.Sospecha de infección de las vías urinarias o infección urológica activa reciente (en los últimos 30 días) (p. ej., prostatitis).
    5.Cualquier hipersensibilidad conocida o contraindicación a alfentanilo, a otros opioides o a anestésicos locales.
    6.Antecedentes o presencia de toxicomanía o alcoholismo.
    7.Uso previo o concomitante de opioides en las 2 semanas anteriores a la administración del PEI.
    8.Uso previo o concomitante de cualquier tratamiento analgésico en las 24 horas anteriores a la administración del PEI.
    9.Uso previo o concomitante de cualquier medicación sedante (como barbitúricos, benzodiacepinas, neurolépticos, antihistamínicos) en las 24 horas anteriores a la administración del PEI.
    10.Uso concomitante de inhibidores de la monoaminooxidasa (p. ej., Aurorix/moclobemida).
    11.Uso previo o concomitante de inhibidores o inductores enzimáticos del citocromo P450 (CYP) 3A4 de intensidad media o alta en los 14 días previos a la administración del PEI (se permite la administración de antibióticos antes de la biopsia, conforme a la práctica estándar del centro, a excepción de los siguientes: claritromicina, eritromicina, telitromicina y rifampina/rifampicina. Véanse en el Anexo 13.2 los medicamentos prohibidos).
    12.Diátesis hemorrágica.
    13.Tratamiento anticoagulante (se permite el ácido acetilsalicílico hasta un máximo de 160 mg/día).
    14.Dolor crónico o necesidad de tratamiento del dolor crónico.
    15.Dolor actual con una puntuación > 3, medida en la Escala de Puntuación Numérica (NRS) de 11 ítems.
    16.Enfermedad grave de las vías respiratorias y los pulmones, como asma significativa, bronquitis crónica, enfisema, síndrome de apnea del sueño o narcolepsia.
    17.Antecedentes de cualquier trastorno convulsivo (aparte de crisis febriles).
    18.Antecedentes de enfermedad renal o hepática importante.
    19.Antecedentes de hipotiroidismo.
    20.Enfermedad cardíaca o enfermedad del sistema nervioso central clínicamente significativa.
    21.Anomalía clínicamente significativa detectada en la exploración física, las constantes vitales (incluidas las anomalías clínicamente significativas de la presión arterial ortostática) o el ECG de 12 derivaciones, según el criterio del investigador.
    22.Antecedentes o presencia de cualquier enfermedad/afección somática que podrían interferir con los objetivos del ensayo según el criterio del investigador.
    23.Participación en cualquier otro ensayo con un PEI en los 3 meses antes de la evaluación de la elegibilidad en la Visita 1.
    24.No apto para participar en el estudio por cualquier otro motivo, a criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Worst pain intensity experienced during prostate biopsy measured immediately after end of prostate biopsy procedure by Numerical Rating Scale (NRS), Direction #2.
    La peor intensidad de dolor experimentada durante la biopsia de próstata medida justo después de finalizar el procedimiento de biopsia de próstata mediante la Escala de Puntuación Numérica (NRS), Instrucción n.º 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    immediately after end of prostate biopsy procedure
    después de finalizar el procedimiento de biopsia de próstata.
    E.5.2Secondary end point(s)
    1. AEs, ECGs, pulse rate, blood pressure, respiratory rate, oxygen saturation (measured by pulse oximetry (SpO2)) and visual inspection of the oral mucosa.

    2a. Independent observer assessment of patient sedation by using Pasero Opioid-induced Sedation Scale (POSS) prior to Investigational Medicinal Product (IMP) administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure.

    2b. Patient subjective assessment of sedation by using Patient Global Impression of Drowsiness (PGID) prior to IMP administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure.

    3. Worst pain intensity experienced during prostate biopsy measured immediately after end of prostate biopsy procedure by NRS.

    4. Pain intensity measured at 10, 30, 60, 90 and 240 minutes after end of prostate biopsy procedure, measured by NRS, Direction #3.

    5a. Patient Global Impression of Satisfaction (PGIS) measured 90 minutes after end of prostate biopsy procedure.
    5b. Clinician Global Impression of Satisfaction (CGIS) measured 90 minutes after end of prostate biopsy procedure.

    6. Percentage of patients receiving rescue medication.

    7. PK parameters

    8. Recovery criteria by Aldrete score prior to IMP administration and at 10, 30, 60, 90, 120, 180 and 240 minutes after end of prostate biopsy procedure.
    1.AA, ECG, pulso, presión arterial, frecuencia respiratoria, saturación de oxígeno (determinada por oximetría de pulso (SpO2)) e inspección visual de la mucosa bucal.

    2a. Evaluación por parte de un observador independiente de la sedación del paciente mediante la Escala de Sedación Inducida por Opioides, de Pasero (POSS) antes de la administración del producto en fase de investigación (PEI), 5 - 10 minutos después de la administración del PEI y a los 10, 30, 60, 90, 120 y 240 minutos de finalizar el procedimiento de biopsia de próstata.

    2b. Evaluación subjetiva de la sedación, efectuada por el propio paciente mediante el cuestionario de Impresión Global de la Somnolencia por parte del Paciente (PGID) antes de la administración del PEI, 5 - 10 minutos después de la administración del PEI y a los 10, 30, 60, 90, 120 y 240 minutos de finalizar el procedimiento de biopsia de próstata.

    3.La peor intensidad de dolor experimentada durante la biopsia de próstata medida justo después de finalizar la biopsia de la próstata por NRS.

    4.Intensidad del dolor medida a los 10, 30, 60, 90 y 240 minutos de finalizar el procedimiento de biopsia de próstata medida por NRS, Instrucción n.º 3.

    5a. Impresión Global de la Satisfacción por parte del Paciente (PGIS) medida 90 minutos después de finalizar el procedimiento de biopsia de próstata.

    5b. Impresión Global de la Satisfacción por parte del Médico (CGIS) medida 90 minutos después de finalizar el procedimiento de biopsia de próstata.

    6.Porcentaje de pacientes que recibieron la medicación de rescate.

    7.Parámetros FC

    8.Criterios de recuperación mediante la puntuación en la Escala de Aldrete antes de la administración del PEI y a los 10, 30, 60, 90, 120, 180 y 240 minutos de finalizar el procedimiento de biopsia de próstata.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Measured during procedure
    2a.prior to Investigational Medicinal Product (IMP) administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure.
    2b.prior to IMP administration, at 5-10 minutes after IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure.
    3. immediately after end of prostate biopsy
    4. measured at 10, 30, 60, 90 and 240 minutes after end of prostate biopsy procedure
    5.90 minutes after end of prostate biopsy procedure.
    6. after last patient/last visit.
    7. after last patient/last visit.
    8. prior to IMP administration and at 10, 30, 60, 90, 120 and 240 minutes after end of prostate biopsy procedure.
    1.Durante el procedimiento
    2a.Antes de la administración del PEI, 5 - 10 minutos después de la administración del PEI y a los 10, 30, 60, 90, 120 y 240 minutos de la biopsia de próstata.
    2b.Antes de la administración del PEI, 5 - 10 minutos después de la administración del PEI y a los 10, 30, 60, 90, 120 y 240 minutos de la biopsia de próstata.
    3.Después de la biopsia de la próstata.
    4.A los 10, 30, 60, 90 y 240 minutos de finalizar la de biopsia de próstata.
    5.90 minutos después de la biopsia de próstata.
    6.Después de última visita /último paciente.
    7.Después de última visita /último paciente.
    8.Antes de la administración del PEI, 5 - 10 minutos después de la administración del PEI y a los 10, 30, 60, 90, 120 y 240 minutos de finalizar la biopsia de próstata.




    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 months2
    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 months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    After trial patients will resume standard hospital care.
    Después del ensayo los pacientes recibirán la asistencia médica habitual.
    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 Decision2012-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-04
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