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Clinical trials for Adverse Drug Events

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   44353   clinical trials with a EudraCT protocol, of which   7380   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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    5,495 result(s) found for: Adverse Drug Events. Displaying page 154 of 275.
    EudraCT Number: 2021-004601-47 Sponsor Protocol Number: CKJX839D12303 Start Date*: 2022-05-09
    Sponsor Name:NOVARTIS PHARMA AG
    Full Title: A multi-center, randomized, double-blind, placebo controlled, parallelgroup Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed ...
    Medical condition: Non-obstructive coronary artery disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004294-13 Sponsor Protocol Number: RD.06.SPR.202699 Start Date*: 2020-10-05
    Sponsor Name:Galderma S.A.
    Full Title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Prurigo Nodularis
    Medical condition: Prurigo Nodularis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10037084 Prurigo nodularis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SE (Trial now transitioned) GB (GB - no longer in EU/EEA) AT (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004824-22 Sponsor Protocol Number: I4T-MC-JVCY Start Date*: 2015-04-24
    Sponsor Name:Lilly S.A.
    Full Title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
    Medical condition: Metastatic Non-Small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) FR (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007769-21 Sponsor Protocol Number: H9D-SB-ITAE Start Date*: 2009-09-11
    Sponsor Name:Lilly Deutschland GmbH
    Full Title: A Randomized, Open-label Study on the Effects of Insulin Pen Devices on Glycemic Control in Children, Adolescents and Adults with Type 1 Diabetes: Novel Pen with Memory Function (HumaPen® Memoir) v...
    Medical condition: Pts with type 1 diabetes mellitus based on the WHO criteria, at least 8 years old, used an insulin pen device to inject at least 4 insulin doses/day for at least 2 months prior to the study and cur...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012602 Diabetes mellitus (incl subtypes) HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-001478-25 Sponsor Protocol Number: ME/2006/2188 Start Date*: 2007-09-12
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: Analgesia provided by intravenous paracetamol compared with intravenous morphine, for pain secondary to islolated limb trauma, in the emergency department: a pilot randomised controlled trial
    Medical condition: Moderate to severe pain caused by limb trauma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10033371 Pain LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-002719-27 Sponsor Protocol Number: GLU2011FC Start Date*: 2011-12-30
    Sponsor Name:AZIENDA OSPEDALIERA DI PARMA
    Full Title: GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS
    Medical condition: PATIENTS WITH CYSTIC FIBROSIS
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011766 Cystic fibrosis pancreatic PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-008656-16 Sponsor Protocol Number: CCD-0901-PR-0012 Start Date*: 2009-11-05
    Sponsor Name:Chiesi Farmaceutici SpA
    Full Title: A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in C...
    Medical condition: COPD
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009032 Chronic obstructive lung disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004760-29 Sponsor Protocol Number: UIAPB-TAHPS-2011-01 Start Date*: 2012-01-16
    Sponsor Name:Maria Victoria Ruiz Arzalluz
    Full Title: EFFECTIVENESS OF ADMINISTRATION TIMING OF ASPIRIN FROM DAYTIME TO NIGHTIME IN HYPERTENSIVE PATIENTS TREATED WITH LOW DOSE OF ASA IN SECONDARY PREVENTION. - TAHPS
    Medical condition: hypertension
    Disease: Version SOC Term Classification Code Term Level
    14.1 10047065 - Vascular disorders 10020775 Hypertension arterial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001208-36 Sponsor Protocol Number: CCD-1103-PR-0058 Start Date*: 2011-08-30
    Sponsor Name:Chiesi Farmaceutici S.p.A
    Full Title: A SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, CLINICAL PHARMACOLOGY STUDY OF CHF 1535 50/6 NEXT DPI® (FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE 50 µg PLUS FORMOTEROL FUMARATE 6 µg ...
    Medical condition: Asthmatic children aged ≥ 5 and < 12 years A part of the asthamatic children (8-10) must be in age range 5-8 years old in order to guarantee a complete representation.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-022947-39 Sponsor Protocol Number: CV203-010 Start Date*: 2011-03-18
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Safety, Tolerability and Effect on Atrial Fibrillation Burden of BMS-914392 in Patients with Paroxysmal Atrial Fi...
    Medical condition: Atrial Fibrillation
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10003661 Atrial fibrillation paroxysmal LLT
    14.1 10007541 - Cardiac disorders 10034039 Paroxysmal atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-001056-22 Sponsor Protocol Number: NDOL-001-2016 Start Date*: 2016-08-24
    Sponsor Name:Medical Univerity Vienna
    Full Title: Neodolpasse® Infusion Solution versus diclofenac 75 mg infusion in the treatment of postoperative pain after elective knee surgery - an exploratory placebo-controlled clinical study to investigate ...
    Medical condition: major elective knee surgery (cruciate ligament surgery)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2005-002157-51 Sponsor Protocol Number: 1034-PhII Start Date*: 2005-08-03
    Sponsor Name:Antares Pharma AG
    Full Title: A Phase II, Single-Center, Open-Label, Parallel, Three-Treatment, Single-Period, Randomized, Single and Multiple-Dose Pharmacokinetic Study of Oxybutynin Gel in Healthy Volunteers
    Medical condition: Study design according to CPMP/EWP/QWP/1401/98 and CPMP/EWP/280/96. Using an open-label, three-treatment, dose-ranging, single-period, randomized, single and multiple-dose design, three treatments ...
    Disease: Version SOC Term Classification Code Term Level
    6.1 10012378 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005508-14 Sponsor Protocol Number: 08/0171 Start Date*: 2010-02-09
    Sponsor Name:University College london
    Full Title: A phase 3 randomized, placebo-controlled blinded investigation of six weeks vs. six months of oral valgancoclovir therapy in infants with symtomatic congenital cytomegalovirus infection. DMID # 06-...
    Medical condition: Symptomatic Congenital Cytomegalovirus.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010430 Congenital cytomegalovirus infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-021141-41 Sponsor Protocol Number: CH/2008/3061 Start Date*: 2011-06-24
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uv...
    Medical condition: Juvenile Idiopathic Arthritis Associated Uveitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10046851 Uveitis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-000776-29 Sponsor Protocol Number: P-Monofer-PREG-01 Start Date*: 2017-05-03
    Sponsor Name:Pharmacosmos A/S
    Full Title: Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: a randomised, comparative, open-label trial
    Medical condition: iron deficiency in pregnant women
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10005329 Blood and lymphatic system disorders SOC
    20.0 10005329 - Blood and lymphatic system disorders 10002041 Anaemia complicating pregnancy, childbirth, or the puerperium LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-003740-11 Sponsor Protocol Number: CCD-0806-PR-0032 Start Date*: 2009-01-23
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: Estudio Fase IV, multinacional, multicéntrico, doble ciego, doble simulación, randomizado, de grupos paralelos, controlado, sobre la combinación de dosis fijas de Dipropionato de Beclometasona 100 ...
    Medical condition: Asma Asthma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10003553 Asthma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-009998-10 Sponsor Protocol Number: MYCUV-IIT02 Start Date*: 2010-02-24
    Sponsor Name:Centre for Ophthalmology, University of Tuebingen
    Full Title: Myfortic (enteric-coated mycophenolate sodium) for the treatment of non-infectous intermediate uveitis – a prospective, controlled randomized multicenter trial
    Medical condition: non-infectious uveitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10015919 - Eye disorders 10046851 Uveitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000786-24 Sponsor Protocol Number: NET-2013-02355002 Start Date*: 2017-03-07
    Sponsor Name:IRCCS Burlo Garofolo
    Full Title: Thalidomide, a novel immunological treatment to modify the natural history of paediatric Crohn's disease: a new proposal from a well-established paediatric research network
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004856 10011402 Crohn's disease (colon) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000755-41 Sponsor Protocol Number: RA/PR/3301/010/03 Start Date*: 2004-09-22
    Sponsor Name:Chiesi Farmaceurtici S.p.A
    Full Title: A three-month, double-blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 µg twice daily of Formoterol-HFA and 12 µg twice daily of Formoterol-DPI (Fo...
    Medical condition: Children Persistent Asthma
    Disease: Version SOC Term Classification Code Term Level
    7.0 10003553 Low
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-000415-25 Sponsor Protocol Number: PROSPER Start Date*: 2018-08-10
    Sponsor Name:University Hospital Heidelberg
    Full Title: PANCREATIC RESECTION WITH PERIOPERATIVE OFF-LABEL STUDY OF PROPRANOLOL AND ETODOLAC – A PHASE II RANDOMIZED TRIAL
    Medical condition: Patients with pancreatic carcinoma treated by pancreatoduodenectomy.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004865 10033659 Pancreatoduodenectomy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    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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