Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Safety management system

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   44334   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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    415 result(s) found for: Safety management system. Displaying page 1 of 21.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2004-001201-10 Sponsor Protocol Number: FEN-PPA-401 Start Date*: 2004-07-26
    Sponsor Name:JANSSEN-CILAG
    Full Title: Comparison of transdermal fentanyl PCA and IV morphine PCA in the management of post-operative pain control.
    Medical condition: Treatment of moderate to severe post-operative pain in subjects who have undergone an elective major abdominal or orthopaedic surgical procedure.
    Disease: Version SOC Term Classification Code Term Level
    6.1 10056350 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-020922-16 Sponsor Protocol Number: BAY 86-5028/15105 Start Date*: 2011-03-01
    Sponsor Name:Bayer Healthcare AG
    Full Title: International, prospective, double-blind, 3-arm comparative, randomized, placebo controlled phase IV study on the effect of counseling and either tranexamic acid or mefenamic acid or placebo, on th...
    Medical condition: Management of bleeding/spotting in women using the levonorgestrel-releasing intrauterine system (Mirena) for contraception.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10046883 Vaginal bleeding LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2008-001173-14 Sponsor Protocol Number: C-2006-007-01 Start Date*: 2008-09-02
    Sponsor Name:Janssen Cilag International N.V.,
    Full Title: An Open-Label Evaluation of Safety of the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40 µg)] for Management of Acute Post- Operative Pain in Pediatric Patients
    Medical condition: The management of acute post operative pain in hospitalized paediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033371 Pain LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (Prematurely Ended) NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002480-30 Sponsor Protocol Number: - Start Date*: 2023-07-18
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial
    Medical condition: 1400 Women with PROM at term and a GBS negative swab
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10073024 Preterm premature rupture of membranes PT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-000529-20 Sponsor Protocol Number: FENHYDPAI4012 Start Date*: 2008-05-20
    Sponsor Name:Janssen-Cilag Limited
    Full Title: Comparison of Ionsys® and routine care with morphine IV PCA in the management of early post-operative mobilisation, ability to mobilise and in time to Fitness For Discharge (FFD)
    Medical condition: Evaluation of the mobilisation characteristics, clinical use, safety and Ease of Care (EOC) of a Fentanyl Iontophoretic Transdermal PCA system (Ionsys) and morphine IV PCA for management of acute...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002235-26 Sponsor Protocol Number: OTR3002 Start Date*: 2011-10-26
    Sponsor Name:Purdue Pharma L.P.
    Full Title: An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study
    Medical condition: Opioid experienced paediatric patients aged 6-17 years with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) EE (Completed) ES (Completed) FI (Completed) DE (Completed) GR (Prematurely Ended) GB (Prematurely Ended) SK (Completed) BE (Completed) HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021955-14 Sponsor Protocol Number: BUP3030 Start Date*: 2011-10-17
    Sponsor Name:Purdue Pharma L.P.
    Full Title: A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged from Birth to 6 Years of Age...
    Medical condition: Acute moderate to severe pain requiring opioids for at least 24 hours in postoperative and prolonged endotracheal intubated patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10002182 Analgesia LLT
    14.0 10042613 - Surgical and medical procedures 10021415 Immediate postoperative analgesia LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002919-33 Sponsor Protocol Number: 207911 Start Date*: 2018-03-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase IV, open-label, randomized study to enrol healthy adult volunteers, naïve to any previous meningococcal vaccination or meningococcal disease, aged 18-50 years, to be either vaccinated with GS...
    Medical condition: Meningitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003480-21 Sponsor Protocol Number: ClinDiab-03 Start Date*: 2012-11-05
    Sponsor Name:Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin. Abt. für Endokrinologie und Stoffwechsel
    Full Title: An open, single-centre, non-controlled feasibility study on the performance of a tablet based workflow and decision support system with incorporated software algorithm used for glycaemic management...
    Medical condition: Diabetes mellitus type 2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004636-19 Sponsor Protocol Number: ENTER_L_01486 Start Date*: 2015-04-10
    Sponsor Name:Sanofi Aventis
    Full Title: Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Da...
    Medical condition: Acute diarrhea
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10000706 Acute diarrhea LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-020510-29 Sponsor Protocol Number: OTR1020 Start Date*: 2010-10-08
    Sponsor Name:Purdue Pharma L.P.
    Full Title: An Open-label Study to Characterise the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release Tablets (ORF) in Paediatric Patients Aged 6 to 16 Years Inclusive, Who Require...
    Medical condition: Post operative and non-surgical paediatric patients, expected to or must have moderate to severe pain requiring oral opioid analgesic treatment for at least 24 hours. Patients must be inpatient for...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10002182 Analgesia LLT
    12.1 10036276 Postoperative analgesia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2014-002405-37 Sponsor Protocol Number: PD2013-002 Start Date*: 2016-11-11
    Sponsor Name:Incline Therapeutics Inc, a wholly owned subsidiary of The Medicines Company
    Full Title: An open label evaluation of the safety and clinical utility of the active, separated system with enhanced controller (SSEC) fentanyl 40 mcg for the management of acute postoperative pain in pediatr...
    Medical condition: Postoperative pain in pediatric inpatients
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004863 10036286 Post-operative pain LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001916-44 Sponsor Protocol Number: MiFlaPRO_2019 Start Date*: 2020-01-28
    Sponsor Name:Medical University Innsbruck, Department of Visceral, Transplant und Thoracic Surgery
    Full Title: A multicenter, randomized, double blind placebo controlled trial of Micronized purified Flavonoid- Fraction (MPFF) in the management of radiation proctitis
    Medical condition: Patients with radiation proctitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003094-10 Sponsor Protocol Number: SPI-GCF-12-201 Start Date*: 2014-01-16
    Sponsor Name:Spectrum Pharmaceuticals
    Full Title: Phase 2, Open-Label, Dose-Ranging Study of HM10460A or Pegfilgrastim use for the Management of Neutropenia in Patients with Breast Cancer who are Candidates for Adjuvant and Neoadjuvant Chemotherap...
    Medical condition: Management of Neutropenia in Patients with Breast Cancer who are Candidates for Adjuvant and Neoadjuvant Chemotherapy with the Docetaxel + Cyclophosphamide (TC) Regimen
    Disease: Version SOC Term Classification Code Term Level
    16.0 10005329 - Blood and lymphatic system disorders 10029354 Neutropenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-000585-30 Sponsor Protocol Number: I16016 Start Date*: 2017-12-13
    Sponsor Name:CHU de Limoges
    Full Title: Pilot study, single-blind, candesartan versus usual care of peripheral neuropathy development induced by vincristine (PNIV) in patients treated for lymphoma B.
    Medical condition: peripheral neuropathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10029205 Nervous system disorders SOC
    20.0 10029205 - Nervous system disorders 10029331 Neuropathy peripheral PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001376-15 Sponsor Protocol Number: VPM1002-DE-3.06CoV Start Date*: 2020-05-13
    Sponsor Name:Vakzine Projekt Management GmbH
    Full Title: A phase III, double-blind, randomized, placebo-controlled multicentre clinical trial to assess the efficacy and safety of VPM1002 in reducing healthcare professionals’ absenteeism in the SARS-CoV-2...
    Medical condition: infectious respiratory diseases (e.g. COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10024970 Respiratory tract infections HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004889-28 Sponsor Protocol Number: FFR113342 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent...
    Medical condition: Rhinitis, Allergic, Perennial
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-005687-97 Sponsor Protocol Number: NoSIRS Start Date*: 2013-06-20
    Sponsor Name:Medtronic Inc.
    Full Title: Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a pilot study
    Medical condition: Possible future indications: inflammatory conditions in general
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001952-16 Sponsor Protocol Number: PTW-1 Start Date*: 2021-01-07
    Sponsor Name:Amsterdam UMC, location VUmc
    Full Title: Progesterone for Breast Development in Trans Women; Assessment of effects and safety -a pilot trial-
    Medical condition: Hormone treatment of transgender women, we will investigate whether addition of progesterone to estradiol treatment results in an increase of breast volume and if there are side effects.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001812-39 Sponsor Protocol Number: TASDA_001 Start Date*: 2017-12-14
    Sponsor Name:Hospital Universitario Vall d'Hebron
    Full Title: Acute uncomplicated diverticulitis: prospective, controlled, randomized, multicenter clinical trial of non-antibiotic outpatient treatment (TASDA trial).
    Medical condition: Uncomplicated acute diverticulitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 02 10:30:55 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA