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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 200 of 1,400.
    «« First « Previous 196  197  198  199  200  201  202  203  204  Next» Last»»
    EudraCT Number: 2016-002743-41 Sponsor Protocol Number: EA-15-01-996 Start Date*: 2016-11-22
    Sponsor Name:Engelhard Arzneimittel GmbH & Co. KG
    Full Title: Prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial to evaluate the efficacy and safety of cineole vs. placebo in the treatment of acute non-purulent rhino...
    Medical condition: Acute, non-purulent rhinosinusitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10052106 Rhinosinusitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000408-71 Sponsor Protocol Number: DEX-11-06 Start Date*: 2017-02-27
    Sponsor Name:Hospira Inc
    Full Title: A Phase II/Ill, Open-Label, Multicenter, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages 28 Weeks to < 36 Weeks Gestational Age
    Medical condition: Initially intubated and mechanically ventilated preterm subjects ... 28 weeks through < 36 weeks, gestational age, having a weight of > 1000 g, in an intensive care setting anticipated to require...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002084-26 Sponsor Protocol Number: MK0991-064 Start Date*: 2017-01-27
    Sponsor Name:Merck Sharp & Dohme Corp.
    Full Title: A Multicenter, Double-Blind, Randomized, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasiv...
    Medical condition: Invasive Candidiasis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10064954 Invasive candidiasis LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002283-41 Sponsor Protocol Number: 151032-002 Start Date*: 2017-09-11
    Sponsor Name:HRA Pharma
    Full Title: A prospective, randomized, parallel-group study to assess the effects on ovarian activity of ellaOne (ulipristal acetate 30 mg single dose) taken after three consecutive days of missed combined ora...
    Medical condition: Emergency contraception
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-002265-21 Sponsor Protocol Number: 207702 Start Date*: 2018-01-18
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A placebo-controlled, double-blind (sponsor open), randomised, crossover study to assess the efficacy, safety, and tolerability of GSK2798745 in participants with chronic cough
    Medical condition: Chronic cough
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10066656 Chronic cough LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004804-23 Sponsor Protocol Number: KCT13/2017–FLEBAVEN/SI Start Date*: 2018-06-15
    Sponsor Name:Krka, d.d., Novo mesto
    Full Title: The efficacy and safety of a single dose Flebavena® (Diosmin) of 1000 mg per day in patients with chronic venous disease (LIGHTEN-UP)
    Medical condition: Patients diagnosed with primary chronic vein disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10066682 Chronic venous insufficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2017-002368-42 Sponsor Protocol Number: LUM-001 Start Date*: 2017-10-12
    Sponsor Name:Lument AB
    Full Title: An open, randomized, controlled, single centre trial to evaluate CT image quality and diagnostic feasibility of Lumentin® 44, a new egg albumen based oral bowel filling agent, in comparison with di...
    Medical condition: None. Lumentin 44 is a contrast agent and the contrast properties will be investigated in this trial. Patients referred to computerised tomography of the abdomen will be included in the trial. Nei...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10011603 CT scan LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005342-63 Sponsor Protocol Number: UoL001206 Start Date*: 2016-06-23
    Sponsor Name:University of Liverpool
    Full Title: Mindex: The efficacy and safety of very low dose dexamethasone used to facilitate the extubation of ventilator dependent preterm babies who are at high risk of bronchopulmonary dysplasia
    Medical condition: Bronchopulmonary dysplasia
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004101-75 Sponsor Protocol Number: S56122-ML10190 Start Date*: 2014-03-28
    Sponsor Name:UZ Leuven
    Full Title: Randomized crossover trial to assess the effects and quality of life in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine in combination with nab-paclitaxel: Q...
    Medical condition: locally advanced or metastatic pancreatic cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10033606 Pancreatic cancer non-resectable LLT
    20.0 100000004864 10033605 Pancreatic cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003585-40 Sponsor Protocol Number: NL.TACRO.10.7.19 Start Date*: 2019-12-17
    Sponsor Name:St. Antonius Hospital
    Full Title: An uncontrolled, open label pilot-study assessing the efficacy in reducing bleeding severity, and the safety of oral tacrolimus in patients with hereditary hemorrhagic telangiectasia
    Medical condition: Gastrointestinal bleeding and epistaxis caused by hereditary hemorrhagic telangiectasia. Hereditary Hemorrhagic Telangiectasia (HHT) is an autosomal dominant inherited disease characterized by muco...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10038554 Rendu-Osler-Weber syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002109-24 Sponsor Protocol Number: E2007-J000-335 Start Date*: 2020-06-17
    Sponsor Name:Eisai Co., Ltd.
    Full Title: A Double-blind, Placebo-controlled, Parallel-group Study With an Openlabel Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subject...
    Medical condition: Refractory Partial-onset Seizures
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004930-41 Sponsor Protocol Number: 9766-CL-0046 Start Date*: 2020-01-22
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 1, Open-Label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
    Medical condition: This is a phase I pharmacokinetic study and does not investigate a medical condition
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003752-36 Sponsor Protocol Number: M16-077 Start Date*: 2020-05-14
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
    Medical condition: Spinal cord injury (SCI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022117 - Injury, poisoning and procedural complications 10041552 Spinal cord injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000953-46 Sponsor Protocol Number: SOV301 Start Date*: 2004-10-13
    Sponsor Name:Amersham plc
    Full Title: A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy and Safety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) in Magnetic Resonance Angiography (MRA) of the Renal Arteries
    Medical condition: Renal artery stenosis (RAS) is implicated as the underlying cause in 1% to 5% of patients with hypertension and 5% to 15% of patients with end-stage renal disease entering dialysis programs each ye...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2004-002769-18 Sponsor Protocol Number: MKC101614 Start Date*: 2005-05-03
    Sponsor Name:GlaxoSmithKline R&D
    Full Title: A 28-day, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, anti-inflammatory effect and steadystate pharmacokinetics of SB-681323 7.5 mg per day in patients wi...
    Medical condition: Chronic Obstructive Pulmonary Disease (COPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) DK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-000501-21 Sponsor Protocol Number: 2003-12 Start Date*: 2005-04-30
    Sponsor Name:XTL Biopharmaceuticals
    Full Title: A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-B, a Mixture of Two Monoclonal Antibodies...
    Medical condition: Hepatic allograft recipients for treatment of hepatitis B virus infection.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-002342-35 Sponsor Protocol Number: SKY0402-C-201 Start Date*: 2005-04-20
    Sponsor Name:SkyePharma, Inc.
    Full Title: A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Escalating/De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained-Release Encapsulated Bupiv...
    Medical condition: Pain following inguinal hernia repair
    Disease: Version SOC Term Classification Code Term Level
    6.0 10022020 LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003258-87 Sponsor Protocol Number: DRI6091 Start Date*: 2006-03-09
    Sponsor Name:Sanofi Aventis Deutschland GmbH
    Full Title: Efficacy and safety of intra-articular multiple doses of 500 µg icatibant including 40 mg triamcinolone as calibrator in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi...
    Medical condition: Subjects with painful osteoarthritis in the knee
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) SI (Completed) LT (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2005-001944-21 Sponsor Protocol Number: PALO-03-14 Start Date*: 2005-09-23
    Sponsor Name:Helsinn Healthcare SA
    Full Title: Multicenter, Phase III, Open-Label, Uncontrolled Study to Assess the Safety and Efficacy of a Single Oral Dose of Palonosetron 0.75 mg in the Prevention of Chemotherapy Induced Nausea and Vomiting ...
    Medical condition: Moderately emetogenic chemotherapy induced nausea and vomiting
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-003518-14 Sponsor Protocol Number: SKY2028-3-003 Start Date*: 2006-01-25
    Sponsor Name:Skyepharma AG
    Full Title: Long-term Open-label Safety Study with SKP Flutiform HFA pMDI (100/10μg and 250/10μg) in Adult and Adolescent Patients with Asthma
    Medical condition: Mild to Moderate-Severe Asthma
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) DE (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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