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    Summary
    EudraCT Number:2018-000242-19
    Sponsor's Protocol Code Number:RHMGSU0241
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-06-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-000242-19
    A.3Full title of the trial
    Change in nutritional state and postoperative outcome following preoperative introduction of nutritional supplements and pancreatic enzymes in patients undergoing Whipple’s procedure for pancreatic cancer (PREPARE): a randomised controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preoperative supplementation of pancreatic enzymes for Whipple’s procedure for malignancies (PREPARE).
    A.3.2Name or abbreviated title of the trial where available
    Preoperative pancreatic enzyme supplementation in Whipple’s procedure
    A.4.1Sponsor's protocol code numberRHMGSU0241
    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 SponsorUniversity Hospitals Southampton NHS Trust
    B.1.3.4Country
    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 supportMylan Products
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAbbott Laboratories Hannover
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportCatalent Schorndorf
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Southampton
    B.5.2Functional name of contact pointSanne Lof
    B.5.3 Address:
    B.5.3.1Street AddressTremona road
    B.5.4Telephone number07483236361
    B.5.6E-mailsanne.lof@uhs.nhs.uk
    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 Creon 25000
    D.2.1.1.2Name of the Marketing Authorisation holderMylan Products Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCreon 25000
    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 INNpancreatin PhEur 300 mg
    D.3.9.3Other descriptive nameCreon 25000
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    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
    Patients undergoing Whipple’s procedure for pancreatic head tumours
    E.1.1.1Medical condition in easily understood language
    Whipple procedure is a major surgical operation involving resection of the pancreas, duodenum, and other organs. This operation is performed to treat cancerous tumours on the head of the pancreas.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033644
    E.1.2Term Pancreaticoduodenectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study question:
    Do preoperative nutritional supplements and pancreatic enzymes have an impact on postoperative outcomes in patients undergoing a Whipples procedure for pancreatic head tumours?
    E.2.2Secondary objectives of the trial
    1. What is the effect of nutritional assessment and support (nutritional supplements, and pancreatic enzymes replacement) on patients’ postoperative outcomes in terms of morbidity and mortality?
    2. What is the effect of nutritional assessment and support (nutritional supplements, and pancreatic enzymes replacement) in improving patients’ preoperative nutritional status compared to nutritional supplementation only?
    3. Does this change of practice lead to any improvement of patients’ preoperative nutritional status?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients with operable pancreatic head or periampullary tumours will be approached for this study.
    Patients are considered operable after discussion in the Hepatobiliary Pancreatic multidisciplinary meeting. Patients are considered operable in the absence of any distant metastasis and/or invasion of the superior meseteric vein and artery.
    E.4Principal exclusion criteria
    Exclusion criteria
    1- Cholangitis / infection requiring hospitalisation.
    2- Previous chemotherapy for this malignancy.
    3- Severe gastric outlet obstruction (stenosis of the duodenum due to tumour growth) defined as vomiting, nausea and/or oral intake less than one /day.
    4- Patients with known malnutrition not related to the pancreatic cancer (anorexia, mal absorption).
    5- Vulnerable patients (Patients who are unable to give consent).
    6- Less than 2 weeks between purported start of nutritional supplementation with or without pancreatic enzyme supplements and the date of pancreatic resection.
    7- Hypersensitivity to Pancreatin of porcine origin or to any of the excipients.
    E.5 End points
    E.5.1Primary end point(s)
    The impact of enzymes supplements on patient’s postoperative outcome (morbidity (severe complications) and mortality) in patients undergoing Whipple’s procedure for pancreatic tumours are the primary end points of this study.
    Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.
    A severe complication is defined as any Clavien-Dindo grade 3-5 complication, (leading to an additional invasive intervention or re-laparotomy with subsequent prolonged hospital stay or death (all cause mortality)) reference Ann Surg. 2004 August; 240(2): 205–213, or readmission for disease related morbidity morbidity 6 weeks after surgery. A comprehensive list of postoperative complications is given in the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.
    E.5.2Secondary end point(s)
    1- Hospital stay
    2- Number of (invasive) diagnostic procedures
    3- Change in nutritional status assessed by changes in: Weight, BMI, SGA, serum albumin, cholesterol HDL, total protein, transferrin, LDH, and variations in SGA, bioelectrical impedance and hand grip assessment.
    4- QoL variation over time
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be followed up to 6 weeks post operatively. This period has been selected as adequate because more than 95% of complications will occur within 30 days after surgery.
    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 No
    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) 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 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 concerned3
    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
    Data collection will complete at the last patients last visit, then data cleaning and analysis will take 6 months before the final report will be submitted.
    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 days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state128
    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)
    This will not be different than expected normal treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation not applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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