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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   44393   clinical trials with a EudraCT protocol, of which   7405   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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    11,458 result(s) found for: Drug Safety. Displaying page 131 of 573.
    «« First « Previous 127  128  129  130  131  132  133  134  135  Next» Last»»
    EudraCT Number: 2005-002978-30 Sponsor Protocol Number: KG2104940 Start Date*: 2005-11-28
    Sponsor Name:GlaxoSmithKlin Research and Development Ltd
    Full Title: A double-blind, randomized, placebo-controlled, repeat dose study to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK189075 with GW869682 in subjects with type 2 diabe...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    7.1 10003601 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022403-22 Sponsor Protocol Number: CLCI699C2201 Start Date*: 2011-07-04
    Sponsor Name:NOVARTIS FARMA
    Full Title: A proof-of concept, open-label, forced titration, multicenter study to assess the safety/tolerability and efficacy of 10-weeks treatment of LCI699 in patients with Cushing’s disease
    Medical condition: Cushing's disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10014698 - Endocrine disorders 10011652 Cushing's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001084-20 Sponsor Protocol Number: TAK-041-2001 Start Date*: 2017-08-16
    Sponsor Name:Takeda Development Centre Europe Ltd.
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Subjects W...
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001159-37 Sponsor Protocol Number: MK-5172-096 Start Date*: 2017-05-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects with Chronic Hepatitis C Virus (HCV) G...
    Medical condition: Hepatitis C Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10076826 Chronic hepatitis C genotype 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003372-23 Sponsor Protocol Number: TMC207-C211 Start Date*: 2015-05-28
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antimycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2015-003647-19 Sponsor Protocol Number: CELIM-NRCD-001 Start Date*: 2016-02-22
    Sponsor Name:Celimmune LLC
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients with Celiac Disease.
    Medical condition: Celiac disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2013-003401-26 Sponsor Protocol Number: 400-12-006 Start Date*: 2014-05-16
    Sponsor Name:Ethicon Inc.
    Full Title: A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery in Pediatric P...
    Medical condition: Abdominal, Retroperitoneal, Pelvic or Thoracic (Non‐Cardiac) Surgery
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002287-31 Sponsor Protocol Number: PREVICHARM Start Date*: 2020-05-22
    Sponsor Name:FIMABIS
    Full Title: Prevention of COVID19 infection with hydroxychloroquine in institutionalized older people and nursing home staff. An open, randomized controlled stepped-wedge clinical trial by clusters. PREVICHARM...
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024270-19 Sponsor Protocol Number: CCD-1014-PR-0053 Start Date*: 2011-05-09
    Sponsor Name:CHIESI
    Full Title: A Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Tolerability of Multiple Dose Regimens of CHF 5074 (200, 400, 600 mg/day for up to 12 Weeks) and to Explore the Eff...
    Medical condition: Mild Cognitive Impairment
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003013-96 Sponsor Protocol Number: AVXCLIN003 Start Date*: 2016-10-03
    Sponsor Name:Avexxin AS
    Full Title: A Randomised, Blinded, Placebo-controlled, Single Centre Pilot Study to evaluate the Safety and Efficacy of AVX001 3% Ointment (NG) administered Topically Once Daily to Patients with mild, moderate...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000482-35 Sponsor Protocol Number: ARA102198 Start Date*: 2004-10-11
    Sponsor Name:GlaxoSmithKline Research & Development Ltd.
    Full Title: A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arth...
    Medical condition: Rheumatoid Arthritis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2008-003865-23 Sponsor Protocol Number: HPN-100-004 Start Date*: 2008-09-08
    Sponsor Name:Hyperion Therapeutics Limited
    Full Title: A Phase 2, Switch-Over, Dose-Escalation Study of the Safety and Tolerability of HPN-100 (glyceryl tri-[4-phenylbutyrate]) Compared to Sodium Phenylbutyrate in Adult and Pediatric Subjects with Urea...
    Medical condition: Urea Cycle Disorder (urea cycle enzyme or transporter deficiency)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-005768-90 Sponsor Protocol Number: OPN-305-104 Start Date*: 2013-04-30
    Sponsor Name:Opsona Therapeutics Ltd
    Full Title: Follow-up Protocol to the Open-Label Phase 0 Part of the Phase II Opsona Study OPN-305-102 (A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adap...
    Medical condition: Prevention of Delayed Graft Function (DGF) following renal transplantation
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004863 10048747 Renal graft function delayed LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005782-12 Sponsor Protocol Number: P-Monofer-PP-01 Start Date*: 2013-04-17
    Sponsor Name:Pharmacosmos A/S
    Full Title: A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose Infusions or Standard Medical Care in Women after Postpartum Haemorrhage
    Medical condition: Postpartum haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    16.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036417 Postpartum haemorrhage PT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-004719-36 Sponsor Protocol Number: CL04041022 Start Date*: 2016-05-14
    Sponsor Name:R-Pharm
    Full Title: A Randomized, Double-Blind, Parallel-Group, Placebo Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arth...
    Medical condition: Moderately to Severely Active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2004-004083-77 Sponsor Protocol Number: NO 002 CS 001 Start Date*: 2004-12-13
    Sponsor Name:Disphar International B.V.
    Full Title: A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate...
    Medical condition: Moderate active Crohn disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005442-23 Sponsor Protocol Number: 411-LY-08-01-0000 Start Date*: 2009-02-19
    Sponsor Name:Leyh Pharma GmbH
    Full Title: Evaluation of the efficacy and safety of nose spray containing 3% silver protein diacetyl tannate (SEAT) in patients with uncomplicated viral rhinitis. A placebo-controlled, randomized, multicentri...
    Medical condition: treatment of uncomplicated rhinal infections
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064948 Viral rhinitis LLT
    9.1 10066743 Acute rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003551-18 Sponsor Protocol Number: AMASCIS-01/2011 Start Date*: 2012-07-23
    Sponsor Name:FIBHULP
    Full Title: Reparative Therapy In Acute Ischemic Stroke With Alogeneic Mesenchymal Stem Cells From Adipose Tissue. Safety Assessment. A Randomised, Double Blind Placebo? Controlled Single Center Pilot Clinical...
    Medical condition: acute ischemic stroke
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000695-41 Sponsor Protocol Number: 67953964MDD2001 Start Date*: 2019-06-27
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Subjects with Ma...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000833-40 Sponsor Protocol Number: CCR4502 Start Date*: 2016-10-07
    Sponsor Name:The Institute of Cancer Research
    Full Title: Phase I ’run in’ study followed by randomised phase II trial testing intra-tumoural hydrogen peroxide as a radiation sensitizer in patients with locally advanced/recurrent breast cancer in terms of...
    Medical condition: Women with locally advanced/recurrent breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
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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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