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    Summary
    EudraCT Number:2011-004988-68
    Sponsor's Protocol Code Number:RINFIS-11
    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:2012-07-09
    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 number2011-004988-68
    A.3Full title of the trial
    Saline solution versus Ringer lactate solution in the initial flluid therapy in the acute pancreatitis
    Suero fisiológico frente a Ringer Lactato en la fluidoterapia inicial de la pancreatitis aguda
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Saline solution versus Ringer Lactate solution in the acute pancreatitis
    Suero fisiológico frente a Ringer Lactato en la pancreatitis aguda
    A.4.1Sponsor's protocol code numberRINFIS-11
    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 SponsorHospital General Universitario de Alicante
    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 supportHospital General Universitario de Alicante
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General de Alicante
    B.5.2Functional name of contact pointEnrique de Madaria Pascual
    B.5.3 Address:
    B.5.3.1Street AddressPintor Baeza 12
    B.5.3.2Town/ cityAlicante
    B.5.3.3Post codeAlicante
    B.5.3.4CountrySpain
    B.5.4Telephone number0034965933468
    B.5.5Fax number0034965913975
    B.5.6E-mailmadaria@hotmail.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 Ringer lactate
    D.2.1.1.2Name of the Marketing Authorisation holderMany companies
    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 nameRINGER LACTATO
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraventricular use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium clorhide
    D.3.9.3Other descriptive nameSODIUM CLORHIDE
    D.3.9.4EV Substance CodeSUB22437
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium lactate
    D.3.9.1CAS number 72-17-3
    D.3.9.3Other descriptive nameSODIUM LACTATE
    D.3.9.4EV Substance CodeSUB15300MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32.9
    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 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 SUERO FISIOLOGICO
    D.2.1.1.2Name of the Marketing Authorisation holderMany companies
    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 nameSUERO SALINO FISIOLOGICO
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium clorhide
    D.3.9.3Other descriptive nameSODIUM CLORHIDE
    D.3.9.4EV Substance CodeSUB22437
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    FLUID THERAPY IN ACUTE PANCREATITIS
    FLUIDOTERAPIA INICIAL EN LA PANCREATITIS AGUDA
    E.1.1.1Medical condition in easily understood language
    FLUID THERAPY IN ACUTE PANCREATITIS
    FLUIDOTERAPIA INICIAL EN LA PANCREATITIS AGUDA
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033647
    E.1.2Term Pancreatitis acute
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the incidence of systemic inflammatory response syndrome and the degree of elevation of CRP at 48-72 hours in patients with acute pancreatitis treated with saline versus Ringer's lactate during the first 72 hours of hospitalization
    Valorar la incidencia de síndrome de respuesta inflamatoria sistémica y el grado de elevación de PCR a las 48-72 horas en pacientes con pancreatitis aguda tratados con suero fisiólogico frente a Ringer Lactato durante las primeras 72 horas de hospitalización.
    E.2.2Secondary objectives of the trial
    To evaluate the incidence of local complications (pancreatic necrosis, acute and collections)
    To evaluate the incidence of organ failure
    Rate of hospital stay
    Assess need for ICU admission
    Valorar la incidencia de complicaciones locales (colecciones agudas y necrosis pancreática)
    Valorar la incidencia de fallo orgánico
    Valorar la estancia hospitalaria
    Valorar necesidad de ingreso en UCI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients over 18 years
    Patients with first episode of acute pancreatitis
    Patients that accept to participate in the trial signing the informed consent
    Pacientes mayores de 18 años
    Pacientes con primer episodio de pancreatitis aguda
    Aceptación libre de participar en el ensayo, con consentimiento informado por escrito del paciente
    E.4Principal exclusion criteria
    -History of severe renal disease
    -Heart failure NYHA functional class> II
    -COPD with home oxygen
    -Suspected or confirmed active infection
    -Sodium Deric Hypernatremia > 1 mEq / L or hyponatremia (<135 mEq / L)
    -Rhabdomyolysis
    -Onset of pain more than 24 hours
    - Metastatic neoplasia
    - Active inflammatory bowel disease
    - Autoimmune disease
    - Active chronic infection (AIDS, tuberculosis)
    -Historia de enfermedad grave renal
    -Insuficiencia cardíaca de clase funcional NYHA > II
    -EPOC con oxigeno domiciliario
    -Infeccion activa sospechada o confirmada
    -Hipernatremia sodio dérico > 1 mEq/L o hiponatremia (<135 mEq/L)
    -Rabdomiolisis
    -Inicio de síntomas de dolor más de 24 horas
    -Neoplasi metastásica
    -Enfermedad inflamatoria intestinal activa
    -Enfermedad autoinmune
    -Infección crónica activa (VIH, tuberculosis)
    E.5 End points
    E.5.1Primary end point(s)
    -Compliance criteria for systemic inflammatory response syndrome (SIRS) from the 24 hours of admission
    -SIRS criteria compliance date.
    -Days until SIRS criteria compliance
    - C-reactive protein in blood at 48 and 72 hours
    -Cumplimiento de criterios de síndrome de respuesta inflamatoria sistémica (SRIS) a partir de las 24 horas de ingreso
    -Fecha de cumplimiento criterios SRIS.
    -Duración en días de cumplimiento de criterios SRIS
    -Proteina C reactiva en sangre a las 48 y 72 horas
    E.5.1.1Timepoint(s) of evaluation of this end point
    24,48, 72 hours
    7 days
    hospital discharged
    24,48, 72 horas
    7 días
    Alta hospitalaria
    E.5.2Secondary end point(s)
    -Severity of acute pancreatitis
    -Development of pancreatic necrosis, acute collections and organ failure
    -Hospital stay in days
    -Need for ICU admission and duration
    -Gravedad de pancreatitis aguda
    -Desarrollo de necrosis pancreática, colecciones agudas y fallo orgánico
    -Estancia hospitalaria en días
    -Necesidad de ingreso en UCI y duración
    E.5.2.1Timepoint(s) of evaluation of this end point
    At hospital discharge
    Al alta hospitalaria
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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
    -The patient has completed the study
    -The patient wants to leave (abandon)
    -The doctor will decide for safety reasons
    -El paciente ha completado el estudio
    -El paciente desea retirarse (abandono)
    -El médico lo decide por motivos de seguridad
    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 months9
    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 months9
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state40
    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)
    Patients do not require treatment after hospital discharge
    Los pacientes no requerirán tratamiento tras el alta hospitalaria
    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 Decision2012-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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