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    The EU Clinical Trials Register currently displays   37950   clinical trials with a EudraCT protocol, of which   6228   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2016-003245-29
    Sponsor's Protocol Code Number:SA652013
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-12-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003245-29
    A.3Full title of the trial
    Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and Sleeve Gastrectomy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass and Sleeve Gastrectomy
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSA652013
    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 SponsorAmsterdam AMC, locatie AMC
    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 supportZambon BV
    B.4.1Name of organisation providing supportSKWOSZ
    B.4.1Name of organisation providing supportZonMW
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, locatie AMC
    B.5.2Functional name of contact pointGastroenterology and Hepatology
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    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. name Ursodeoxycholic acid
    D. of the Marketing Authorisation holderZambon Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    Prevention of symptomatic gallstone disease
    E.1.1.1Medical condition in easily understood language
    Prevention of symptoms due to gallstones
    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
    This study is designed to provide evidence regarding the prophylactic use of UDCA in preventing symptomatic gallstone disease after bariatric surgery.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the assessment of the health care efficiency of prophylactic use of UDCA and its budget impact.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Scheduled to undergo Roux-en-Y gastric bypass or Sleeve Gastrectomy for morbid obesity
    • An intact gallbladder
    E.4Principal exclusion criteria
    • Symptomatic gallstone disease already present before RYGB or Sleeve Gastrectomy
    • Prior bariatric surgery
    • Prior gallbladder surgery
    • Ascertained or presumptive hypersensitivity to active or excipient ingredients of UDCA.
    • Inflammatory bowel disease and other conditions of the small intestine and liver which may interfere with enterohepatic circulation of bile salts (ileal resection and stoma, extra and intra-hepatic cholestasis, severe liver disease)
    • Intake of investigational drug within the last 30 days before the screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is symptomatic gallstone disease after 24 months, defined as hospital admission or hospital visit for symptomatic gallstone disease.

    Hospital visit is a condition, because all patients with noteworthy symptoms will eventually visit the hospital. Mild and self-limiting complaints are not a large burden to the health care system or to the patient, and usually gallstone involvement is not objectified in these patients.

    Symptomatic gallstone disease is defined as biliary disease (biliary pancreatitis, acute cholecystitis, choledocholithiasis, cholangitis, or biliairy colics).

    Acute pancreatitis is diagnosed when at least two of the three following features are present: 1. Upper abdominal pain; 2. Serum lipase or amylase levels above three times the upper level of normal; 3. Characteristic findings of acute pancreatitis on cross-sectional abdominal imaging. (40) Biliary pancreatitis is diagnosed when one of the following definitions is present 1. Gallstones and/or sludge diagnosed on imaging (transabdominal or endoscopic ultrasound or computed tomography); 2. In the absence of gallstones and/or sludge, a dilated common bile duct on ultrasound (>8 mm in patients ≤75 years old or >10 mm in patients >75 years old); 3. The following laboratory abnormality: alanine aminotransferase (ALT) level >2 times higher than normal values, with ALT >aspartate aminotransferase.

    Acute cholecystitis is defined according to the 2007 Tokyo classification. There must be at least one local sign of inflammation: 1. Murphy’s sign; 2. Right upper quadrant mass/pain/tenderness. And at least one systemic sign of inflammation: 1. Fever; 2. Elevated C-reactive protein; 3. Elevated white blood cell count. Positive imaging findings characteristic of acute cholecystitis confirm the diagnosis in case of clinical suspicion.

    Biliary colics are defined as upper abdominal pain (either right upper quadrant or epigastric pain) lasting at least 30 minutes with gallstones visible on abdominal imaging, according to the Rome criteria.

    Choledocholithiasis is defined as the presence of stones in the extrahepatic bile ducts as proven by clinical imaging OR clinical suspicion based on abnormal liver function tests in combination with upper abdominal pain for which an ERCP or PTC was indicated.

    Cholangitis is diagnosed according to the diagnostic criteria of the updated Tokyo Guidelines (TG13). Suspected diagnosis: One item in A + one item in either B or C.
    A. Systemic inflammation
    A-1. Fever and/or shaking chills (BT >38 °C)
    A-2. Laboratory data: evidence of inflammatory response (abnormal white blood cell count, increase of serum C-reactive protein levels, and other changes indicating inflammation)
    B. Cholestasis
    B-1. Jaundice (T-Bil ≥ 34 ╬╝mol/L)
    B-2. Laboratory data: abnormal liver function tests (increased serum alkaline phosphatase, gamma-glutamyl transpeptidase, alanine aminotransferase, aspartate aminotransferase levels >1.5x higher than the upper limit of normal value)
    C. Imaging
    C-1. Biliary dilatation
    C-2. Evidence of the etiology on imaging (stricture, stone, stent etc.)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months after surgery.
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    1. The development of gallstones on ultrasound at 24 months in the gallstone negative group.
    2. Number of cholecystectomies in the intervention and the placebo group.
    3. Side-effects of UDCA.
    4. Therapy compliance.
    5. Quality of life, cost-effectiveness, cost-utility and budget impact analyses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    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 Yes
    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. 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
    Last visit of last subject in the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 980
    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 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 state980
    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)
    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 Decision2016-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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