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Clinical trials for Rehydration

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    18 result(s) found for: Rehydration. Displaying page 1 of 1.
    EudraCT Number: 2019-000367-25 Sponsor Protocol Number: AURIGA Start Date*: 2019-04-17
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    Full Title: Acute effect of parenteral rehydration solution commonly used in children with acute gastroenteritis on acid-base balance, free-fatty acids metabolism and glucose homeostasis
    Medical condition: Dehydration and metabolic acidosis due to acute gastroenteritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10012174 Dehydration PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019787-36 Sponsor Protocol Number: FARM8E53XM Start Date*: 2011-07-04
    Sponsor Name:ISTITUTO PER L`INFANZIA BURLO GAROFOLO
    Full Title: ORAL ONDANSETRON VS DOMPERIDONE FOR SYMPTOMATIC TREATMENT OF VOMITING DURING ACUTE GASTROENTERITIS IN CHILDREN: MULTICENTRE RANDOMIZED CONTROLLED TRIAL
    Medical condition: Acute gastroenteritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066762 LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002601-19 Sponsor Protocol Number: OND-URG Start Date*: 2019-09-16
    Sponsor Name:Basque Health Service
    Full Title: Effectiviness and safety of the administration of ondansetron versus placebo for the treatment of vomit in children with mild and moderate dehydration: randomized clinical trial
    Medical condition: Vomiting
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002004-92 Sponsor Protocol Number: OralRehyd Start Date*: 2015-09-09
    Sponsor Name:Medizinische Universität Graz, Klinische Abteilung für allgemeine Pädiatrie
    Full Title: Acute gastroenteritis in paediatrics : Comparison of two oral rehydration preparations - A randomized pilot study
    Medical condition: acute gastroenteritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10017784 Gastric flu LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000970-10 Sponsor Protocol Number: LPS16140 Start Date*: 2020-09-09
    Sponsor Name:Sanofi Aventis Groupe
    Full Title: Phase III, randomized, double blind, parallel groups, clinical trial to evaluate the efficacy and safety of Bacillus clausii versus placebo in the prevention of antibiotic associated diarrhea (AAD)...
    Medical condition: Antibiotic associated diarrhea (AAD) in children
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10064065 Prophylaxis against diarrhoea PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004621-40 Sponsor Protocol Number: NL50760 Start Date*: 2015-09-07
    Sponsor Name:University Medical Center Groningen
    Full Title: The effect of oral ondansetron on referral rate in children aged 6 months to 6 years attending in primary care out of hours service with acute gastro-enteritis and vomiting.
    Medical condition: Gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-005165-31 Sponsor Protocol Number: LPS14914 Start Date*: 2020-05-14
    Sponsor Name:Sanofi Aventis Groupe
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Comparative Study to Assess the Efficacy and Safety of Spores of Enterogermina in Combination with Oral Rehydration Ther...
    Medical condition: Acute diarrhea
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10012735 Diarrhoea PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003943-30 Sponsor Protocol Number: VomED Start Date*: 2005-11-22
    Sponsor Name:University of Leipzig
    Full Title: Doubleblind randomized multicenter trial to investigate the influence of dimenhydrinate suppositories vs. placebo on oral rehydration in infants and children with infectious enteritis and vomiting
    Medical condition: Infectious enteritis with vomiting
    Disease: Version SOC Term Classification Code Term Level
    8.1 10058839 Enteritis infectious PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-001342-13 Sponsor Protocol Number: 136/2007/O/Sper Start Date*: 2008-02-19
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: Effectiveness on the clinical outcome of an oral enterovaccine (Colifagina) and evaluation of the role of the Astrovirus in the aetiology of the pathology of acute gastroenteritis in children.”
    Medical condition: acute gastroenteritis in children.”
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017893 Gastroenteritis astroviral LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003444-37 Sponsor Protocol Number: ENTERR06929 Start Date*: 2016-08-26
    Sponsor Name:Sanofi
    Full Title: Bacillus clausii in the treatment of acute community–acquired diarrhea among Latin American children (cadiLAc)
    Medical condition: Diarrhea
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004856 10000706 Acute diarrhea LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004636-19 Sponsor Protocol Number: ENTER_L_01486 Start Date*: 2015-04-10
    Sponsor Name:Sanofi Aventis
    Full Title: Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Da...
    Medical condition: Acute diarrhea
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10000706 Acute diarrhea LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003582-25 Sponsor Protocol Number: NL59128 Start Date*: 2017-01-23
    Sponsor Name:University Medical Center Groningen
    Full Title: The added effect of oral ondansetron to care-as-usual on persisting vomiting in children aged 6 months to 6 years, presenting at primary care out of hours service with acute gastro-enteritis and co...
    Medical condition: Gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005700-15 Sponsor Protocol Number: marha1983 Start Date*: 2013-01-07
    Sponsor Name:Lennart Svensson Linköping University Medical Faculty
    Full Title: Can 5-HT3 receptor antagonists be used to limit vomiting in rota- and norovirus infections?
    Medical condition: Virus caused vomiting and effect of the antiemetic drug Ondansetron
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001541-92 Sponsor Protocol Number: 444563/028/029/030,107070,72,76 Start Date*: 2015-06-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavir...
    Medical condition: Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005950-27 Sponsor Protocol Number: 202100762 Start Date*: 2023-03-29
    Sponsor Name:University Medical Center Groningen
    Full Title: Molecular Imaging of Zirconium-89-labeled Brentuximab as a Tool to Investigate brentuximab biodistribution in CD30-positive Lymphoma
    Medical condition: All patients with histologically proven CD30-positive (i.e. > 1% cells) lymphomas who will be treated with brentuximab vedotin, including: Hodgkin lymphoma, T-cell lymphoma, Cutaneous T-cell lympho...
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001651-31 Sponsor Protocol Number: 1.0 Start Date*: 2017-11-30
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: EMPOWER: EMesis in Pregnancy - Ondansetron With mEtoclopRamide.
    Medical condition: Nausea and Vomiting in pregnancy Hyperemesis gravidarum
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004797-18 Sponsor Protocol Number: Start Date*: 2017-06-26
    Sponsor Name:Imperial College London
    Full Title: Pilot study of the GLP-1 agonist, Liraglutide, on decreasing parenteral support requirements in short bowel patients.
    Medical condition: Intestinal failure with an underlying aetiology of short bowel
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-000256-28 Sponsor Protocol Number: LAP117314 Start Date*: 2014-08-21
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Randomised, Multicentre, Open Label, Phase II study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib with Capecitabine for t...
    Medical condition: Diarrhoea associated with treatment with lapatinib and capecitabine for metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Completed) GB (Completed) IT (Completed) GR (Completed) PL (Completed) FR (Completed)
    Trial results: View results
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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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