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Clinical trials for Sphincter of Oddi

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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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    4 result(s) found for: Sphincter of Oddi. Displaying page 1 of 1.
    EudraCT Number: 2018-004239-63 Sponsor Protocol Number: NL68231.078.18 Start Date*: 2019-08-23
    Sponsor Name:Erasmus MC
    Full Title: Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy. PROFIT study.
    Medical condition: Post-operative pancreatic fistula
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10049192 Pancreatic fistula PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-006001-35 Sponsor Protocol Number: PREBOT-II Start Date*: 2021-10-27
    Sponsor Name:University Hospital Heidelberg
    Full Title: Randomized controlled trial of PREoperative injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leakage after hepatic resection PREBOT-II
    Medical condition: Patients undergoing partial hepatic resection for various underlying diseases.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10077348 Liver resection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002461-35 Sponsor Protocol Number: PREBOTPilot Start Date*: 2019-12-06
    Sponsor Name:Ruprecht-Karls-University Heidelberg Medical Faculty represented by Universitätsklinikum Heidelberg and its acting Comm
    Full Title: Monocenter, randomized, controlled, open-label, phase-II clinical trial of PREoperative endoscopic injection of BOTulinum toxin in the sphincter of Oddi to reduce postoperative pancreatic fistula a...
    Medical condition: Elective distal pancreatectomy for any underlying disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10013476 Distal pancreatectomy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-005216-15 Sponsor Protocol Number: ABO-NB-15 Start Date*: 2016-07-06
    Sponsor Name:ABOCA S.P.A. SOCIETà AGRICOLA
    Full Title: Relief of heartburn and epigastric pain comparing Neobianacid® with omeprazole: a randomized, double blind, double dummy, reference product controlled, parallel group, non-inferiority clinical study
    Medical condition: GERD (Gastroesophageal Reflux Disease) and/or EPS (Epigastric Pain Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10015015 Epigastric burning LLT
    20.1 100000004856 10066998 Gastroesophageal burning LLT
    20.1 100000004856 10066990 Gastrooesophageal burning LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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