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    Summary
    EudraCT Number:2020-004298-35
    Sponsor's Protocol Code Number:RCT-PRO-PEP-INDO-RING
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004298-35
    A.3Full title of the trial
    PROPHYLAXIS OF POST-ERCP ACUTE PANCREATITIS: A RANDOMISED, MULTICENTRE, OPEN-LABEL STUDY COMPARING INDOMETHACIN VERSUS INDOMETHACIN AND RINGER LACTATE COMBINATION
    LA PROFILASSI DELLA PANCREATITE ACUTA POST-ERCP: STUDIO RANDOMIZZATO, MULTICENTRICO, IN APERTO, DI CONFRONTO TRA INDOMETACINA VERSO ASSOCIAZIONE INDOMETACINA E RINGER LATTATO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylaxis of acute pancreatitis arising following ERCP (a procedure that uses endoscopy and radiology to study the bile and pancreatic ducts) comparing the administration of Indomethacin versus the combination of Indomethacin with Lactated Ringer.
    Profilassi della pancreatite acuta insorta a seguito di ERCP (procedura che utilizza l’endoscopia e la radiologia per studiare i dotti biliari e pancreatici) confrontando la somministrazione di Indometacina versus la combinazione di Indometacina con Ringer lattato.
    A.3.2Name or abbreviated title of the trial where available
    PEPPER
    PEPPER
    A.4.1Sponsor's protocol code numberRCT-PRO-PEP-INDO-RING
    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 SponsorAZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL - IRCCS di Reggio Emilia
    B.5.2Functional name of contact pointInfrastruttura ricerca e statistica
    B.5.3 Address:
    B.5.3.1Street AddressViale Umberto I, 50
    B.5.3.2Town/ cityReggio Emilia
    B.5.3.3Post code42123
    B.5.3.4CountryItaly
    B.5.6E-mailmassimo.costantini@ausl.re.it
    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.2.5The 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 nameIndometacina
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Suppository
    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 INNINDOMETACINA
    D.3.9.1CAS number 53-86-1
    D.3.9.2Current sponsor codeIndometacina
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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 Lattato
    D.3.2Product code [NA]
    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 INNACIDO LATTICO/SODIO IDROSSIDO/SODIO CLORURO/POTASSIO CLORURO/CALCIO CLORURO
    D.3.9.2Current sponsor codeRinger lattato
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Study objective: prophylaxis for Acute Pancreatitis post-ERCP (PEP).
    ERCP refers to endoscopic retrograde cholangiopancreatography: it is an endoscopic procedure using radiological imaging. It is used for the diagnosis and treatment of benign and malignant biliary and pancreatic diseases. The most common complication is acute post-ERCP pancreatitis (PEP).
    Obiettivo di studio: profilassi per la Pancreatite Acuta post-ERCP (PEP).
    Per ERCP si intende colangiopancreatografia retrograda endoscopica: è una procedura endoscopica che si serve di immagini radiologiche. Viene adoperata per la diagnosi e il trattamento di patologie biliari e pancreatiche benigne e maligne. La complicanza più comune è la pancreatite acuta post-ERCP (PEP).
    E.1.1.1Medical condition in easily understood language
    Acute pancreatitis
    Pancreatite acuta
    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 20.0
    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
    Comparing the incidence of PEP in patients undergoing ERCP and randomised to receive 2 different prophylaxis regimens
    Confrontare l’incidenza di PEP in pazienti sottoposti a ERCP e randomizzati a ricevere 2 diversi regimi di profilassi
    E.2.2Secondary objectives of the trial
    To evaluate the effect of the 2 different prophylaxis regimens on:
    1. Severity of pancreatitis
    2. Increase in amylase and lipase values
    3. Occurrence of any adverse events
    4. Average length of hospitalisation
    Valutare l’effetto dei 2 diversi regimi di profilassi su:
    1. Gravità delle pancreatiti
    2. Incremento dei valori di amilasi e lipasi
    3. Comparsa di eventuali eventi avversi
    4. Durata media dei ricoveri
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years;
    - All naïve patients consecutively undergoing ERCP and with any indication;
    - Informed consent obtained.
    • Età > 18 anni;
    • Tutti i pazienti naïve consecutivamente sottoposti a ERCP e con qualsiasi indicazione;
    • Ottenimento del consenso informato.
    E.4Principal exclusion criteria
    - Refusal or inability to sign informed consent;
    - Patients with ongoing acute pancreatitis;
    - Patients with known allergy/hypersensitivity to NSAIDs;
    - Patients with hypersensitivity to the active substance(s) or to any of the excipients of Ringer Lactate;
    - Patients with a personal or family history of Stevens-Johnson syndrome or Lyell syndrome;
    - Patients already treated with NSAIDs within 7 days prior to ERCP;
    - Patients with recent gastrointestinal bleeding (less than 30 days after ERCP), or with a history of recurrent bleeding/ulcer peptic ulcer or bleeding/perforation after previous NSAID treatment;
    - Patients undergoing endoscopic papillectomy;
    - Patients with a positive history of recent myocardial infarction (less than 6 months after the procedure), heart failure, severe myocardial insufficiency (NYHA class > II), respiratory insufficiency with chronic need for oxygen therapy, known pulmonary hypertension;
    - Patients with ventricular fibrillation;
    - Patients with ongoing therapy with cardioactive glycosides;
    - Patients with chronic renal insufficiency (creatinine clearance values below 40 ml/min);
    - cirrhotic patients in Child B and C class;
    - Patients with severe hydro-electrolyte imbalances (hypernatremia > 150 mEq/L, hyponatremia < 130 mEq/L; hypercalcemia, hyperkalemia).
    - Metabolic and respiratory alkalosis;
    - Patients with epilepsy or Parkinson's disease;
    - Patients with psychiatric disorders;
    - Patients with a history of major surgery of the upper digestive tract (Billroth II, Roux-en-Y anastomosis);
    - Pregnancy or lactation;
    - Sarcoidosis;
    - Untreated Addison's disease;
    - Active proctitis of any aetiology.
    • Rifiuto o impossibilità a firmare il consenso informato;
    • Pazienti con pancreatite acuta in atto;
    • Pazienti con nota allergia/ipersensibilità a FANS;
    • Pazienti con ipersensibilità ai principi attivi o a uno qualsiasi degli eccipienti del Ringer lattato;
    • Pazienti con storia personale o familiare di sindrome di Stevens-Johnson o di Lyell;
    • Pazienti già sottoposti a trattamento con FANS nei 7 giorni prima dell’ERCP;
    • Pazienti con recente emorragia gastrointestinale (a meno di 30 giorni dall’ERCP), o con storia di emorragia/ulcera peptica ricorrente o di emorragia/perforazione dopo precedenti trattamenti con FANS;
    • Pazienti sottoposti a papillectomia endoscopica;
    • Pazienti con anamnesi positiva per recente infarto miocardico (a meno di 6 mesi dalla procedura), scompenso cardiaco, severa insufficienza miocardiaca (classe NYHA > II), insufficienza respiratoria con necessità in cronico di ossigeno-terapia, nota ipertensione polmonare;
    • Pazienti con fibrillazione ventricolare;
    • Pazienti con terapia in atto con glicosidi cardioattivi;
    • Pazienti con insufficienza renale cronica (valori di clearance della creatinina inferiori a 40 ml/min);
    • Pazienti cirrotici in classe Child B e C;
    • Pazienti con severi squilibri idro-elettrolitici (ipernatriemia > 150 mEq/L, iponatriemia < 130 mEq/L; ipercalcemia, iperKaliemia).
    • Alcalosi metabolica e respiratoria;
    • Pazienti affetti da epilessia o morbo di Parkinson;
    • Pazienti affetti da disturbi psichiatrici;
    • Pazienti con storia di chirurgia maggiore del tratto digestivo superiore (Billroth II, anastomosi Roux-en-Y);
    • Gravidanza o allattamento;
    • Sarcoidosi;
    • Malattia di Addison non trattata;
    • Proctite attiva di qualsiasi eziologia.
    E.5 End points
    E.5.1Primary end point(s)
    The onset of post-ERCP acute pancreatitis (PEP)
    Insorgenza di pancreatite acuta post-ERCP (PEP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 hours after the procedure (according to Cotton's criteria)
    A 24 ore dalla procedura (secondo i criteri di Cotton)
    E.5.2Secondary end point(s)
    1. Severity of post-ERCP acute pancreatitis (PEP) according to Atlanta criteria; 2. Difference in plasma amylase and lipase level post-ERCP compared to baseline; 3. Intra- and post-procedural adverse events with particular reference to:
    • intra-operative bleeding
    • postoperative bleeding
    • increased plasma creatinine compared to baseline
    • pulmonary oedema
    • water overload
    • other; 4. Average length of stay
    1. Gravità della pancreatite acuta post-ERCP (PEP) secondo i criteri di Atlanta; 2. Differenza del livello plasmatico di amilasi e lipasi post-ERCP rispetto al baseline; 3. Eventi avversi intra e post-procedurale con particolare riferimento a:
    • sanguinamento intra-operatorio;
    • sanguinamento post-operatorio
    • aumento della creatinina plasmatica rispetto al baseline
    • edema polmonare
    • sovraccarico idrico
    • altro; 4. Durata media di ricovero
    E.5.2.1Timepoint(s) of evaluation of this end point
    72 hours after the onset of acute pancreatitis; At 24 hours; • Intra-operative bleeding (during surgery)
    • Postoperative bleeding (within 30 days of the procedure);
    • Increased plasma creatinine compared to baseline (at 24 hours post-procedure);
    • Pulmonary oedema (2, 8 and 24 hours after the procedure);
    • Water overload (2, 8 and 24 hours after the procedure);
    • Other (events occurring during the hospital stay and related to the procedure or study).; Until the end of hospitalisation
    A 72 ore dalla insorgenza della pancreatite acuta; A 24 ore; • Sanguinamento intra-operatorio (durante l'intervento)
    • Sanguinamento post-operatorio (entro 30gg dall’intervento);
    • Aumento della creatinina plasmatica rispetto al baseline (a 24 ore dalla procedura);
    • Edema polmonare (a 2, 8 e 24 ore dalla procedura);
    • Sovraccarico idrico (a 2, 8 e 24 ore dalla procedura);
    • Altro (eventi occorsi durante la degenza e correlabili alla procedura o allo studio).; Fino alla fine del ricovero
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Combinazione indometacina con ringer lattato
    Combination indomethacin with ringer lactate
    E.8.2.4Number of treatment arms in the trial2
    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 concerned13
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 1250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 625
    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 state1250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1250
    F.4.2.2In the whole clinical trial 1250
    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)
    The patient will be managed in the study with active monitoring until discharge and with telephone monitoring until day 30 after randomisation.
    Il paziente sarà gestito nello studio con monitoraggio attivo fino alla dimissione e con monitoraggi telefonici fino al 30° giorno dalla randomizzazione.
    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 Decision2021-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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