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Clinical trials for Pharmacovigilance

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
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    35 result(s) found for: Pharmacovigilance. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-002770-43 Sponsor Protocol Number: CUN-OMAL-UCOL Start Date*: 2013-10-28
    Sponsor Name:Clínica Universidad de Navarra/Universidad de Navarra
    Full Title: Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.
    Medical condition: Cholinergic urticaria
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-009596-35 Sponsor Protocol Number: Start Date*: 2009-03-17
    Sponsor Name:Queen Mary's, University of London
    Full Title: Optimisation of Peri-operative Cardiovascular Management to Improve Surgical Outcome (Optimise Trial)
    Medical condition: Post-operative complications in patients who undergo major surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2023-000765-14 Sponsor Protocol Number: 217270 Start Date*: 2023-10-03
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A prospective, multi-center post marketing surveillance (PMS) study to monitor the safety of GlaxoSmithKline Biologicals’ SA’s (GSK) Meningococcal Group B (Bexsero) vaccine in Korean participants, ...
    Medical condition: The study will collect real-world post-vaccination adverse events.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2016-001789-28 Sponsor Protocol Number: IG1601 Start Date*: 2018-04-25
    Sponsor Name:Instituto Grifols S.A.
    Full Title: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites
    Medical condition: Subjects with decompensated cirrhosis and ascites
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10064704 Decompensated cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Ongoing) FR (Ongoing) BE (Completed) GB (GB - no longer in EU/EEA) DK (Completed) IT (Ongoing) HU (Completed) BG (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001787-10 Sponsor Protocol Number: IG1407 Start Date*: 2019-01-12
    Sponsor Name:Instituto Grifols S.A.
    Full Title: Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality
    Medical condition: Subjects with cirrhosis with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during hospitalization
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10064704 Decompensated cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) PT (Completed) DE (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) DK (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002446-21 Sponsor Protocol Number: ARTROCELL Start Date*: 2020-04-20
    Sponsor Name:IBSAL (Instituto de Investigación Biomédica de Salamanca)
    Full Title: Phase III, multicentre, randomized, open clinical trial comparing treatment with allogenic mesenchymal cells against autologous mesenchymal cells and against active control with hyaluronic acid in ...
    Medical condition: Knee osteoarthritis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000294-78 Sponsor Protocol Number: CTP001H Start Date*: 2019-06-07
    Sponsor Name:Nektr Technologies
    Full Title: A Randomized, Single-Blinded, Comparative Study of Mycosinate and Curanail in the Treatment of Fungal Nail Infection
    Medical condition: Onychomycosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004131-23 Sponsor Protocol Number: GA1212 Start Date*: 2013-01-18
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Ltd
    Full Title: A single-centre, randomised, 2 way crossover, double blind, placebo controlled study in healthy volunteers, to characterise the antacid activity of Gaviscon Double Action Mint Liquid in the fasted ...
    Medical condition: This study is to demonstrate the antacid action of Gaviscon Double Action Mint versus a matched placebo using a pH catheter.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002677-19 Sponsor Protocol Number: IG1605 Start Date*: 2019-07-24
    Sponsor Name:Instituto Grifols S.A.
    Full Title: Pathogenesis of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) in Decompensated Cirrhotic Subjects with Systemic Inflammatio...
    Medical condition: Group 1 and 2: Subjects with cirrhosis with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during hospitalization Group 3: Subject with cirrhosis hospitalized for Acute decompensat...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10064704 Decompensated cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) DE (Prematurely Ended) FR (Completed) AT (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005275-24 Sponsor Protocol Number: TACPKPD Start Date*: 2016-03-18
    Sponsor Name:HOSPITAL UNIVERSITARI DE BELLVITGE
    Full Title: Conversion pharmacodynamic study in stable renal transplant patients receiving tacrolimus two times a day to a new formulation of tacrolimus - LCP Tacro - 1 time a day.
    Medical condition: REJECTION PROPHYLAXIS IN RENAL TRANSPLANT PATIENTS
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10050436 Prophylaxis against renal transplant rejection LLT
    18.1 10042613 - Surgical and medical procedures 10038533 Renal transplant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006404-11 Sponsor Protocol Number: PERFECT001(M-2006-144) Start Date*: 2008-03-19
    Sponsor Name:Miltenyi Biotec GmbH
    Full Title: INTRAMYOCARDIAL TRANSPLANTATION OF BONE MARROW STEM CELLS FOR IMPROVEMENT OF POST-INFARCT MYOCARDIAL REGENERATION IN ADDITION TO CABG SURGERY: a controlled prospective, randomized, double blinded m...
    Medical condition: Coronary artery disease after myocardial infarction with an indication for CABG surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10007541 - Cardiac disorders 10028596 Myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Temporarily Halted)
    Trial results: View results
    EudraCT Number: 2012-005333-36 Sponsor Protocol Number: ALLOB-DU1 Start Date*: 2013-07-30
    Sponsor Name:Bone Therapeutics S.A.
    Full Title: A pilot Phase I/IIa, multicentre, open proof-of-concept study on the efficacy and safety of allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures
    Medical condition: Non-infected delayed-union fractures
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10017081 Fracture delayed union PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002651-25 Sponsor Protocol Number: R119220 Start Date*: 2017-07-11
    Sponsor Name:Research Governance and Integrity, University of Manchester
    Full Title: A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis
    Medical condition: Early diffuse cutaneous systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10012977 Diffuse systemic sclerosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-004473-25 Sponsor Protocol Number: 242-12-232 Start Date*: 2018-09-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Phase 1, Open-label, Multiple-dose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Pat...
    Medical condition: Pediatric patients with multidrug-resistant tuberculosis (MDRTB) who are receiving an optimized background regimen (OBR) of Antituberculosis Drugs
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004620-38 Sponsor Protocol Number: 242-12-233 Start Date*: 2019-01-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC 67683) in Pediatric Multidrug-resistant Tuberculosis Patients on Therap...
    Medical condition: Pediatric patients with multidrug-resistant tuberculosis (MDR-TB) who are receiving an optimized background regimen (OBR) of antituberculosis drugs
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2012-004470-25 Sponsor Protocol Number: GA1214 Start Date*: 2013-01-08
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Ltd
    Full Title: A multicentre, randomised, double-blind, two arm, parallel group, pilot study to assess the effect of Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to onc...
    Medical condition: Patients with Gastro Oesophageal Reflux Disease (GORD) with inadequate response to PPI treatment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-000381-36 Sponsor Protocol Number: 26083 Start Date*: 2006-04-26
    Sponsor Name:University of Nottingham
    Full Title: Randomised controlled trials to investigate whether prophylactic antibiotics can prevent further episodes of cellulitis (erysipelas) of the leg (PATCH I & PATCH II)
    Medical condition: Cellulitis of the leg
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004109-28 Sponsor Protocol Number: GA1211 Start Date*: 2013-01-18
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Ltd
    Full Title: A randomised, 4 way crossover, double blind, placebo controlled pilot study in patients with reflux symptoms, to assess suppression of gastro-oesophageal reflux by ‘Gaviscon Double Action Mint ’ us...
    Medical condition: This study assesses suppression of gastro-oesophageal reflux of Gaviscon in patients with gastro-oesophageal reflux disease.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001177-32 Sponsor Protocol Number: HEP101 Start Date*: 2016-08-09
    Sponsor Name:Promethera Biosciences
    Full Title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure
    Medical condition: The study will recruit cirrhotic patients who are hospitalized for Acute-on-chronic liver failure (ACLF) or Acute Decompensation at risk of developing ACLF. ACLF combines an acute deterioration of...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10008954 Chronic liver disease and cirrhosis LLT
    20.1 100000004871 10049844 Acute liver failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) BG (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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