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Clinical trials for GRAS

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   44335   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).

    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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    12 result(s) found for: GRAS. Displaying page 1 of 1.
    EudraCT Number: 2015-001614-94 Sponsor Protocol Number: 15-PP-03 Start Date*: 2015-07-03
    Sponsor Name:Centre Hospitalier Universitaire de Nice
    Full Title: Hepatoprotective role of SMOFlipid® used in short-term parenteral nutrition in an Onco-Hematology Pediatric Population, pilot study
    Medical condition: parenteral nutrition in an Onco-Hematology Pediatric Population
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10065877 Dietary and nutritional therapies HLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-024547-32 Sponsor Protocol Number: RBHP 2010 AZARNOUSCH Start Date*: 2011-03-17
    Sponsor Name:CHU Clermont-Ferrand
    Full Title: Effets potentiels d’une supplémentation en oméga 3 sur la membrane des cardiomyocytes de patients atteints d’athérosclérose coronaire ?
    Medical condition: patients avec indication de chirurgie de revascularisation coronaire
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002791-33 Sponsor Protocol Number: 2007-17 Start Date*: 2008-04-16
    Sponsor Name:Assistance Publique Hopitaux de marseille
    Full Title: Effet aigu d’une insulinothérapie intensive sur le métabolisme des lipoparticules riches en triglycérides (LRT) intestinales chez le patient diabétique de type 2
    Medical condition: DIABETIQUE DE TYPE II
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005706-11 Sponsor Protocol Number: Cyst2016_01 Start Date*: 2016-03-14
    Sponsor Name:Vita Green Europa S.A.
    Full Title: Single-site, open, randomized clinical trial to assess the non-inferiority of Cysticlean® versus Fosfomicina in the treatment of cystitis in women in Spain.
    Medical condition: Urinary Tract Infection (UTI)
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10011790 Cystitis escherichia PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002446-37 Sponsor Protocol Number: PHRI06-FL / CarniPréma Start Date*: 2007-11-13
    Sponsor Name:CHRU de Tours
    Full Title: Effets de la supplémentation parentérale en carnitine chez le nouveau-né prématuré
    Medical condition: La prématurité
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036590 Premature baby LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001448-78 Sponsor Protocol Number: Cyst2018_01 Start Date*: 2018-11-08
    Sponsor Name:Vita Green Europa S.A.
    Full Title: Single-site, open, randomized clinical trial to assess the non-inferiority of Cysticlean® versus Fosfomicina in the treatment of cystitis in women in Spain.
    Medical condition: Urinary Tract Infection (UTI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10011790 Cystitis escherichia PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-014869-43 Sponsor Protocol Number: 2008_47/0928 Start Date*: 2009-12-21
    Sponsor Name:Centre Hospitalier Régional et Universitaire
    Full Title: Influence des acides gras polyinsaturés à longue chaîne n-3 sur l'expression des mucines dans la muqueuse nasale de patients atteints de mucoviscidose
    Medical condition: Mucoviscidose
    Disease: Version SOC Term Classification Code Term Level
    12.0 10028141 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005619-28 Sponsor Protocol Number: 2012.786 Start Date*: 2014-07-23
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Influence of lipid emulsions for parenteral nutrition on the fonctional state of cutaneous barrier
    Medical condition: patients avec une insuffisance intestinale chronique sévère recevant une nutrition parentérale au long cours
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10051284 Parenteral nutrition PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004756-38 Sponsor Protocol Number: 2018-1201 Start Date*: 2019-02-12
    Sponsor Name:Institut de Cancérologie Lucien Neuwirth
    Full Title: Study of thromboelastography during tranexamic acid treatment in preventing bleeding in patients with haematological malignancies presenting severe thrombocytopenia (TTRAP-bleeding)
    Medical condition: Malignant hemopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004402-55 Sponsor Protocol Number: 6344-001A Start Date*: 2020-11-09
    Sponsor Name:Baxter Healthcare Corporation
    Full Title: A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (lip...
    Medical condition: Essential Fatty Acid Deficiency (EFAD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10015486 Essential fatty acid deficiency LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019373-15 Sponsor Protocol Number: 291202BS Start Date*: 2010-06-15
    Sponsor Name:Marinomed Biotechnologie GmbH
    Full Title: A phase IIa, single-center, randomized, reference-controlled, observer-blind trial to assess the efficacy of a topical Aescin formulation in experimentally induced itch, wheal and flare reactions i...
    Medical condition: subjects with proven type I allergy against one of the three allergens: grass pollen, tree pollen, cat epithelia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036019 Pollen allergy LLT
    12.1 10066093 Birch pollen allergy LLT
    12.1 10001742 Allergy to animal LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002406-32 Sponsor Protocol Number: 2018-0601 Start Date*: 2018-11-19
    Sponsor Name:Institut de Cancérologie Lucien Neuwirth
    Full Title: HOMEORAD : Randomized Phase III Trial Evaluating Homeopathic Radium Bromatum® Impact on the Prevention and Treatment of Radiodermites in Breast Cancer Patients
    Medical condition: Indication of curative radiotherapy after conservative breast cancer surgery. Accepted scheme of radiotherapy: 50 Gy (main) + 16 Gy on the tumoral bed (supplement of dose).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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