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Clinical trials for SAFETY

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   44380   clinical trials with a EudraCT protocol, of which   7392   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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    27,999 result(s) found for: SAFETY. Displaying page 534 of 1,400.
    «« First « Previous 530  531  532  533  534  535  536  537  538  Next» Last»»
    EudraCT Number: 2016-005023-92 Sponsor Protocol Number: 4658-203 Start Date*: 2017-03-28
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy
    Medical condition: Patients with Duchenne Muscular Dystropy Amenable to Exon 51 Skipping
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000019-26 Sponsor Protocol Number: D5670C00013 Start Date*: 2018-05-04
    Sponsor Name:MedImmune Limited, a wholly owned subsidiary of AstraZeneca
    Full Title: A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects with Type 2 Diabetes Mellitus and Renal Impairment
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000596-27 Sponsor Protocol Number: VAC52150EBL2001 Start Date*: 2015-05-18
    Sponsor Name:Janssen Vaccines & Prevention BV
    Full Title: A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebol...
    Medical condition: Ebola
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10014071 Ebola disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002252-27 Sponsor Protocol Number: TED-C14-006 Start Date*: 2016-09-19
    Sponsor Name:NPS Pharmaceuticals, Inc.
    Full Title: A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age with Short Bowel Syndrome who are Dependent ...
    Medical condition: Short Bowel Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003147-35 Sponsor Protocol Number: M14-567 Start Date*: 2014-12-16
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (R...
    Medical condition: Chronic Hepatitis C Virus (HCV) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-004888-37 Sponsor Protocol Number: FFR111158 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spr...
    Medical condition: Irritant (non-allergic) rhinitis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002154-36 Sponsor Protocol Number: CIGE025F1301 Start Date*: 2019-02-13
    Sponsor Name:Novartis Pharma KK
    Full Title: A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Adult and Adolescent Patients With Inadequately Controlled...
    Medical condition: Severe Japanese cedar pollinosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10036020 Pollinosis LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005064-42 Sponsor Protocol Number: AF219-012 Start Date*: 2016-02-26
    Sponsor Name:Afferent Pharmaceuticals, Inc.
    Full Title: A 12-Week Study to Assess the Efficacy and Safety of AF-219 in Subjects with Treatment Refractory Chronic Cough
    Medical condition: Chronic Cough
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-004753-33 Sponsor Protocol Number: CSLCT-QIV-15-03 Start Date*: 2016-12-15
    Sponsor Name:Seqirus GmbH
    Full Title: A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-li...
    Medical condition: Prophylaxis for influenza virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000592-24 Sponsor Protocol Number: MR308-3501 Start Date*: 2017-03-15
    Sponsor Name:Mundipharma Research GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Multicenter, Placebo- and active Comparator-Controlled Study to evaluate Efficacy and Safety of MR308 in the Treatment of Acute Pain After Third Molar Tooth Extraction (...
    Medical condition: Acute pain after third molar tooth extraction; dental procedure must have involved extraction of at least two impacted third molars requireing bone removal. If only two impacted third molars are ex...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000023314 10066714 Acute pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003962-24 Sponsor Protocol Number: 6632-9050-04 Start Date*: 2016-12-27
    Sponsor Name:Medice Arzneimittel Pütter GmbH & Co. KG
    Full Title: A multi-centre, randomized, placebo-controlled, double-blind, parallel-group study investigating safety and efficacy of a sore throat lozenge in the symptomatic treatment of patients with acute pha...
    Medical condition: Acute Pharyngitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002449-71 Sponsor Protocol Number: LP0084-1193 Start Date*: 2015-12-23
    Sponsor Name:LEO Pharma A/S
    Full Title: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest including 12-month follow-up Part 1: 3-day treatment period including an 8-week follow-up period Part 2:...
    Medical condition: Actinic Keratosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002349-50 Sponsor Protocol Number: M16TGA Start Date*: 2017-09-29
    Sponsor Name:Netherlands Cancer Institute- Antoni van Leeuwenhoek Hospital (NKI-AVL)
    Full Title: Phase I/II study with galunisertib (LY2157299) combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer and an activated TGF-β signature
    Medical condition: colorectal carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002011-21 Sponsor Protocol Number: MARACOVID Start Date*: 2020-06-02
    Sponsor Name:Fundación para la Investigación e Innovación Biomédica del Hospital Universitario Infanta Leonor y Sureste (FIIB)
    Full Title: Bicentric, phase 2, randomized, open-label study to evaluate the efficacy and safety of maraviroc associated with standard treatment in hospitalized patients with pulmonary SARS-CoV-2 infection (CO...
    Medical condition: COVID-19 Pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004925-42 Sponsor Protocol Number: P04824 Start Date*: 2015-04-13
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis
    Medical condition: Acute Bacterial Sinusitis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003345-29 Sponsor Protocol Number: 3568 Start Date*: 2016-11-16
    Sponsor Name:Kings College Hospital NHS Foundation Trust
    Full Title: Safety of tenofovir alafenamide (TAF) in patients with a history of tubulopathy on tenofovir disoproxil fumarate (TDF)
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-003972-42 Sponsor Protocol Number: A1281198 Start Date*: 2020-08-21
    Sponsor Name:Pfizer, Inc.
    Full Title: A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPO...
    Medical condition: Bipolar Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10004938 Bipolar disorders HLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-000061-37 Sponsor Protocol Number: PR-002 Start Date*: 2008-04-02
    Sponsor Name:EURAND SPA
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase™ (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreati...
    Medical condition: Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003635-23 Sponsor Protocol Number: XIG-AP 1 Start Date*: 2008-08-14
    Sponsor Name:Central Manchester and Manchester Children's Hospitals NHS Trust
    Full Title: A PRELIMINARY EVALUATION OF THE SAFETY PROFILE OF TWENTY-FOUR HOUR INFUSION OF HUMAN RECOMBINANT ACTIVATED PROTEIN C (XIGRIS) EARLY IN SEVERE ACUTE PANCREATITIS.
    Medical condition: Severe acute pancreatitis in man (with an APACHE II score of ≥ 15) appears to carry a considerably higher risk of death when compared to general critical care patients with similar APACHE II scores...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033647 Pancreatitis acute LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-006488-22 Sponsor Protocol Number: E2007-G000-227 Start Date*: 2007-10-03
    Sponsor Name:Eisai Limited
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients with Painful Diabetic Neuropathy
    Medical condition: Painful Diabetic Neuropathy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012680 Diabetic neuropathy LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) DE (Completed) GB (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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