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Clinical trials for Drug 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   44336   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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    11,447 result(s) found for: Drug safety. Displaying page 1 of 573.
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    EudraCT Number: 2021-002073-26 Sponsor Protocol Number: 1125-ECIR Start Date*: Information not available in EudraCT
    Sponsor Name:Medical Center - University of Freiburg
    Full Title: Phase 1/2 Trial to determine the safety and efficacy of Extracorporeal photopheresis as treatment for steroid-refractory immune related adverse events after immune checkpoint inhibitor therapy
    Medical condition: Immune related adverse events induced by treatment with immune checkpoint inhibitors (monoclocanl antibodies against PD-1, PD-L1 or CTLA-4)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10022117 - Injury, poisoning and procedural complications 10043408 Therapeutic agent toxicity LLT
    26.1 10018065 - General disorders and administration site conditions 10067033 Drug side effect LLT
    24.0 10018065 - General disorders and administration site conditions 10061623 Adverse drug reaction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-005235-14 Sponsor Protocol Number: P05042 Start Date*: 2007-07-11
    Sponsor Name:Integrated Therapeutics Group Inc
    Full Title: A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users
    Medical condition: Opioid dependence
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013663 Drug dependence LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) ES (Completed) CZ (Completed) PT (Completed) SI (Completed) DE (Completed) IE (Completed) IT (Completed) LT (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2022-002462-32 Sponsor Protocol Number: SHW01 Start Date*: 2022-12-09
    Sponsor Name:Suchthilfe Wien gGmbH
    Full Title: Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.
    Medical condition: Opioid dependence: Opioid dependence is a serious and usually chronic disease that requires treatment, encompasses various psychological and physical dimensions, and is associated with concomitant ...
    Disease: Version SOC Term Classification Code Term Level
    26.1 10037175 - Psychiatric disorders 10013658 Drug addiction LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-005234-21 Sponsor Protocol Number: P04843 Start Date*: 2007-11-28
    Sponsor Name:Schering-Plough Research Institute
    Full Title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.
    Medical condition: Opioid dependance
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013663 Drug dependence LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) SE (Completed) PT (Completed) DK (Completed) LT (Completed) SI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-001088-28 Sponsor Protocol Number: BRIO Start Date*: 2016-01-14
    Sponsor Name:South London and Maudsley NHS Foundation Trust [...]
    1. South London and Maudsley NHS Foundation Trust
    2. King's College London
    Full Title: Feasibility, efficacy and acceptability of injected buprenorphine as treatment for opiate users who persist in injecting illicit heroin through opiate maintenance treatment
    Medical condition: Addiction to illicit heroin
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10019935 Heroin addiction LLT
    18.1 100000004873 10001127 Addiction to drugs LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003901-93 Sponsor Protocol Number: RC2019.1.6_GIAQUINTO Start Date*: 2020-05-27
    Sponsor Name:IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    Full Title: Monocentric, indipendent, phase II clinical trial, randomized in open to three different lZ delivery sequences in pediatric patients aged 1 and 12, in intensive care and mechanically ventilated.
    Medical condition: Critical patients subjected to mechanical ventilation and hospitalized in PICU
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004266-18 Sponsor Protocol Number: LTF-307 Start Date*: 2020-09-03
    Sponsor Name:bluebird bio, Inc.
    Full Title: Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector
    Medical condition: Subjects with sickle-cell disease treated with gene therapy drug products in a bluebird bio-sponsored study will be invited to participate in this long-term follow-up study to monitor the safety an...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10040648 Sickle cell SC disease LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003282-16 Sponsor Protocol Number: HA006 Start Date*: 2005-11-04
    Sponsor Name:Nuvelo, Inc.
    Full Title: PHASE 3, MULTICENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALFIMEPRASE IN SUBJECTS WITH OCCLUDED CENTRAL VENOUS ACCESS DEVICES
    Medical condition: Central venous access device occlusion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000780-24 Sponsor Protocol Number: 9463-CL-2303 Start Date*: 2012-07-24
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis
    Medical condition: Neonatal Candidiasis
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-001043-37 Sponsor Protocol Number: LORA01 Start Date*: 2015-06-30
    Sponsor Name:Erasmus MC
    Full Title: Pharmacokinetics of Lorazepam Oral Liquid in Paediatric ICU Patients
    Medical condition: Withdrawal
    Disease: Version SOC Term Classification Code Term Level
    19.0 10018065 - General disorders and administration site conditions 10013754 Drug withdrawal syndrome PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001280-23 Sponsor Protocol Number: ISO-MTX-003 Start Date*: 2013-09-19
    Sponsor Name:Isofol Medical AB
    Full Title: An Open-Label, Multicenter, Phase I/II Clinical Trial to Identify the Modufolin® Dose with Most Favorable Safety Prospect and Confirmed Ability to Mitigate High-Dose Methotrexate Induced Toxicity d...
    Medical condition: Rescue after High Dose Methotrexate therapy in Osteosarcoma patients.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10061814 Detoxification PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-004603-78 Sponsor Protocol Number: MK-0869-097-02 Start Date*: 2015-02-13
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Preventio...
    Medical condition: chemotherapy induced nausea and vomiting
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004827-29 Sponsor Protocol Number: VX14-661-110 Start Date*: 2015-09-01
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, ...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed) IE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) SE (Completed) AT (Completed) FR (Completed) DK (Completed) NL (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004460-63 Sponsor Protocol Number: EXPO Start Date*: 2019-07-01
    Sponsor Name:South London and Maudsley NHS Foundation Trust [...]
    1. South London and Maudsley NHS Foundation Trust
    2. King's College London
    Full Title: Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO): An Open Label Randomised Controlled Trial of Injectable Depot Maintenance Buprenorphine versus Standard-Of-Care Oral Maintenance Opi...
    Medical condition: Opiod addiction
    Disease: Version SOC Term Classification Code Term Level
    23.1 10037175 - Psychiatric disorders 10013658 Drug addiction LLT
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-000777-80 Sponsor Protocol Number: SENS111-202 Start Date*: 2018-06-08
    Sponsor Name:Sensorion
    Full Title: A randomized, cross-over, placebo controlled, and meclizine calibrated study to assess the safety and pharmacodynamic effects of SENS-111 (100 mg and 200 mg) single dose in healthy subjects exposed...
    Medical condition: healthy volunteers (medicine for acute unilateral vertigo)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2004-002802-31 Sponsor Protocol Number: PENT-IBD-CH CZ Start Date*: 2005-01-25
    Sponsor Name:Ferring-Leciva, a.s.
    Full Title: Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets versus Pentasa® tbl. 500mg in Children with Crohn´s Disease
    Medical condition: children patients with the Crohn s disease in any stage (where mesalazine treatment is appropriate)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-002805-13 Sponsor Protocol Number: LTF-304 Start Date*: 2015-11-27
    Sponsor Name:bluebird bio, Inc
    Full Title: Longterm Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product
    Medical condition: Cerebral Adrenoleukodystrophy (CALD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10051260 Adrenoleukodystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-004775-36 Sponsor Protocol Number: DETOX-11 Start Date*: 2012-01-30
    Sponsor Name:GET SRL
    Full Title: ''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms d...
    Medical condition: Oppiate addicts(heroin, methadone and buprenorphine)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10032707 Other specified drug dependence, continuous use LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000579-19 Sponsor Protocol Number: MAGNET Start Date*: 2021-06-25
    Sponsor Name:Stichting TRICALS Foundation
    Full Title: A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS)
    Medical condition: Amyotrophic Lateral Sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (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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