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    Summary
    EudraCT Number:2011-004397-28
    Sponsor's Protocol Code Number:PANPAIN/1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-07
    Trial 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 number2011-004397-28
    A.3Full title of the trial
    Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study.
    Eficacia de la pregabalina en el tratamiento del dolor en el cáncer de páncreas. Ensayo aleatorio, controlado a doble ciego y con grupos paralelos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of pregabalin in the treatment of pancreatic cancer pain.
    Eficacia de la pregabalina en el tratamiento del dolor en el cáncer de páncreas.
    A.4.1Sponsor's protocol code numberPANPAIN/1
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de salut MAR)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPartial funded by a grant from Lyrica Investigator Initiated Research Awards 2011, Pfizer, Inc.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Institut Mar d'Investigacions Mèdiques (IMIM)
    B.5.2Functional name of contact pointServei de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressDr. Aiguader 88
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number3493316 06 70
    B.5.5Fax number3493316 05 72
    B.5.6E-mailrecerca@imim.es
    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 Lyrica hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePregabalin
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.2Current sponsor codePregabalin
    D.3.9.3Other descriptive namePREGABALIN
    D.3.9.4EV Substance CodeSUB10023MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 300
    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 placeboCapsule, hard
    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
    Pancreatic cancer induced abdominal pain
    Dolor abdominal inducido por el cáncer de páncreas
    E.1.1.1Medical condition in easily understood language
    Pancreas cancer pain
    Dolor en el cáncer de páncreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 pregabalin in pancreatic cancer induced abdominal pain
    Evaluar la eficacia analgésica de la pregabalina en el dolor abdominal inducido por el cáncer de páncreas
    E.2.2Secondary objectives of the trial
    1. To analyze the effect on quality of life of treatment with the co-analgesic pregabalin in pancreatic cancer patients.
    2. To compare adverse effects induced by pregabalin to those induced by conventional treatment (WHO cancer pain recommendations).
    3. To evaluate anxiety and depression in pancreatic cancer patients treated with pregabalin and to compare it with patients treated conventionally (WHO cancer pain recommendations).
    1. Analizar el efecto de la pregabalina sobre la calidad de vida de los pacientes con cáncer de páncreas tratados con este fármaco.
    2. Comparar los efectos adversos inducidos por la pregabalina con los inducidos por el tratamiento convencional (recomendaciones de la OMS sobre el dolor en el cáncer) en pacientes con cáncer de páncreas.
    3. Evaluar el nivel de ansiedad y depresión en los pacientes con cáncer de páncreas tratados con pregabalina, y compararlo con el de los pacientes tratados de manera convencional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
    2. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
    3. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
    4. Negative pregnancy test during the previous 2 weeks before study treatment in all women in fertile age. Postmenopausal women should present amenorrhea at least 12 months before to consider they are not in fertile age.
    1. Pacientes mayores de 18 años recientemente (< 3 meses) diagnosticados de cáncer de páncreas
    2. Pacientes que firmen el consentimiento informado indicando que han sido iformados de todos los aspectos pertinentes sobre el ensayo.
    3. Pacientes con predisposición y capaces de acudir a las visitas programadas, cumplir el plan de tratamiento y someterse a las pruebas de laboratorio y otros procedimientos del ensayo.
    4. Prueba de embarazo negativa en las dos semanas previas del inicio del tratamiento (suero) en todas las mujeres en edad fértil. Las mujeres posmenopáusicas deben presentar amenorrea desde hace al menos 12 meses para considerar que no están en edad fértil.
    E.4Principal exclusion criteria
    1. Patients with evidence or history of medical or surgical disease of importance fot this study as judged by investigator.
    2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60 mL/min should be excluded.
    3. Patients treated with anticonvulsants during the previous 4 months.
    4. Patients showing hypersensitivity to the active drug or any its excipients as described in pregabalin drug sheet.
    5. Pregnant women not using efficacious method of contraception and women in breastfeeding period.
    1. Pacientes con evidencia o antecedentes médicos o quirúrgicos relevantes para el estudio.
    2. Pacientes con insuficiencia renal moderada-severa. Aquellos con aclaramiento de creatinina < 60 mL/min serán excluidos.
    3. Pacientes tratados con antiepilépticos durante los 4 meses previos.
    4. Pacientes con hipersensibilidad al principio activo o a alguno de los excipientes tal como indica la ficha técnica de la pregabalina.
    5. Personas embarazadas que no utilicen medios eficaces anticonceptivos y mujeres en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI).
    Efecto analgésico de la pregabalina en pacientes con cáncer de páncreas, medido con una escala visual analógica (EVA), el cuestionario breve de dolor (BPI) y el cuestionario de síntomas de dolor neuropático (NPSI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 : baseline/randomization: day 0.
    Visit 2: day +30.
    Visit 3: day +60.
    Visit 4: day +90.
    Visita 1 : base/aleatorización: día 0.
    Visita 2: día +30.
    Visita 3: día +60.
    Visita 4: día +90.
    E.5.2Secondary end point(s)
    1. Changes in quality of life compared to baseline level using SF-12 quality of life questionnaire.
    2. Performance status (Karnofsky Performance Status Scale).
    3. Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).
    1. Cambios en la calidad de vida de los pacientes comparado con el nivel de base usando el cuestionario SF-12.
    2. Funcionalidad de los pacientes mediante la escala de valoración funcional de Karnofsky.
    3. Nivel de ansiedad y depresión medido mediante la escala hospitalaria de ansiedad y depresión (HAD).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 : baseline/randomization: day 0.
    Visit 2: day +30.
    Visit 3: day +60.
    Visit 4: day +90.
    Visita 1 : base/aleatorización: día 0.
    Visita 2: día +30.
    Visita 3: día +60.
    Visita 4: día +90.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    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
    End of trial is defined as LSLV.
    El ensayo clínico terminará cuando se realice la ultima visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state72
    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)
    All patients will be proposed to continue follow up after the end of the study in a multidisciplinary Pain Unit. Treatment with pregabalin will be continued if effective in patients treated during the study.
    Se propondrá a todos los participantes en el estudio la posibilidad de continuar siendo tratados en una Unidad de Dolor multidisciplinar. Aquellos pacientes tratados con pregabalina durante el estudio en los que esta fuere eficaz, podrán continuar con dicho tratamiento.
    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 Decision2012-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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