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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2014-004844-37
    Sponsor's Protocol Code Number:ACG-CR-065-2013
    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:2015-05-08
    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 number2014-004844-37
    A.3Full title of the trial
    A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
    Ensayo piloto controlado y aleatorizado con indometacina en pancreatitis aguda.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of indomethacin in pancreatitis
    Ensayo con indometacina en pancreatitis
    A.4.1Sponsor's protocol code numberACG-CR-065-2013
    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 SponsorEnrique de Madaria Pascual
    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 supportUniversitiy of Pittsburgh Medical Center. Division of Gastroenterology
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnrique de Madaria Pascual
    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 code03010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34965913975
    B.5.5Fax number+349659139
    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 ARTRINOVO DEBIL SUPOSITORIOS
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS LLORENS
    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.3.4Pharmaceutical form Rectal capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDOMETHACIN SODIUM TRIHYDRATE
    D.3.9.2Current sponsor code620385
    D.3.9.4EV Substance CodeSUB02677MIG
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboRectal capsule
    D.8.4Route of administration of the placeboRectal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute pancreatitis
    Pancreatitis aguda
    E.1.1.1Medical condition in easily understood language
    Pancreatitis
    Pancreatitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Evaluate the efficacy of rectal indomethacin on attenuating systemis inflammation in patients with AP who also have SIRS
    Evaluar el efecto de la Indometacina administrada vía
    rectal en la inflamación sistémica medida por el cambio en la puntuación del
    Score de SRIS y en los niveles de PCR después de 48 horas de tratamiento
    en pacientes con PA y SRIS
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients ages 18 or above admitted to hospital with a diagnosis of Acute pancreatitis (AP) based on at least 2 of the followin criteria: (i)abdominal pain characteristic of AP; (ii) serum amylase and/or lipase>= 3 times the upper limit of normal; and/or (iii) characteristic findings of AP on abdominal CT scan .

    Patients with SIRS (<= 2 of the following criteria: temperature <36ºC or >38ºC, heart rate >90/min, respiratory rate >20/min or PaCO2<32 mm Hg , WBC<4,000/mm3, >12,000/mm3 or >10% bands) upon hospital admission or who develop SIRS within 48 hrs of admission.
    Pacientes mayores de 18 años que acudan al hospital con diagnóstico de pancreatitis aguda basado en al menos 2 de los siguientes criterios: (i)Dolor abdominal característico de Pancreatitis aguada (AP); (ii) amilasa y/or lipasa>= 3 veces del límite superior de normalidad; y/o (iii) Hallazgos característicos de AP en las pruebas de imagen.

    Pacientes con SIRS (<= 2 de los siguientes criterios: temperatura <36ºC o >38ºC, frcuencia cardiaca >90/min, frecuencia respiratoria >20/min or PaCO2<32 mm Hg , Leucocitos<4,000/mm3, >12,000/mm3 or >10%formas inmaduras) al ingreso o quienes lo desarrollen en las primeras 24 h
    E.4Principal exclusion criteria
    More than 48 hrs since the onset of abdominal paien, absence of SIRS within 48 hrs of presentation, presence of OF, presence of renal dysfunction, active peptic ulcer disease, use of daily NSAIDs within 1 week of presentation and or allergy to NSAIDs.
    Mas de 48 horas desde el inicio del dolor abdominal, ausencia de SRIS en las primeras 48 horas, presencia de FO, presencia de fallo renal, úlcera peptica activa, uso diario de AINEs dentro de la primera semana de presentación del cuadro y/o alergia a los mismos.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in systemic inflammation as measured by change in the mean SIRS score prior to and at 48 hrs following initiation of the intervention.
    Reducción dela inflamación sistémica medida como un cambio en la media de la puntuación SRIS antes y a las 48 h del inicio del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hrs
    48 h
    E.5.2Secondary end point(s)
    Not applicable
    No Aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 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) 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 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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    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
    Ninguna
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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