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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   44381   clinical trials with a EudraCT protocol, of which   7393   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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    11,457 result(s) found for: Drug Safety. Displaying page 203 of 573.
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    EudraCT Number: 2016-002781-31 Sponsor Protocol Number: PQBirch301 Start Date*: 2017-02-16
    Sponsor Name:Allergy Therapeutics (UK) Ltd
    Full Title: A multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Birch Modified Allergen Tyrosine adsorbed + MPL in the prevention of season...
    Medical condition: Seasonal allergic rhinoconjunctivitis due to birch pollen
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000014962 10001728 Allergic rhinoconjunctivitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) SE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003428-35 Sponsor Protocol Number: KSI-CL-102 Start Date*: 2020-01-03
    Sponsor Name:Kodiak Sciences Inc.
    Full Title: A Phase 2b/3, Prospective, Randomised, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in S...
    Medical condition: Neovascular (Wet) Age-related Macular Degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.1 10015919 - Eye disorders 10067791 Wet macular degeneration LLT
    20.0 10015919 - Eye disorders 10015919 Eye disorders SOC
    20.0 10015919 - Eye disorders 10071129 Neovascular age-related macular degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) GB (GB - no longer in EU/EEA) DE (Prematurely Ended) CZ (Prematurely Ended) SK (Prematurely Ended) PL (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-002967-23 Sponsor Protocol Number: M-17923-30 Start Date*: 2022-01-27
    Sponsor Name:Almirall, S.A.
    Full Title: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients ...
    Medical condition: atopic dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004858 10003639 Atopic dermatitis LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) ES (Completed) PL (Completed) BE (Completed) IT (Completed) NL (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002773-64 Sponsor Protocol Number: RP103-07 Start Date*: 2014-01-22
    Sponsor Name:Horizon Pharma USA, Inc.
    Full Title: A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis
    Medical condition: Cystinosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011777 Cystinosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-000608-14 Sponsor Protocol Number: 1.0/170119 Start Date*: Information not available in EudraCT
    Sponsor Name:Tartu University Hospital
    Full Title: Prospective validation of individualized Bayesian dose optimization tool DosOpt for Vancomycin treatment in neonates.
    Medical condition: In neonatal population wide inter-and intra-individual variability of pharmacokinetics makes extremely difficult to ensure optimal exposure of vancomycin with standard regimens. On average >50% of ...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004791-19 Sponsor Protocol Number: CACN00177-100D Start Date*: 2020-05-11
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: A Phase 1/2 Multiple Ascending-Dose Study in Subjects With Homocystinuria Due to Cystathionine β-Synthase (CBS) Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of ACN00177
    Medical condition: Homocystinuria Due to Cystathionine β-Synthase (CBS) Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10020365 Homocystinuria PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-001319-39 Sponsor Protocol Number: 18/2008/U/Sper Start Date*: 2008-04-11
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: PROtection of coronary Microcirculation by Iloprost: Safety and Efficacy in Percutaneous Coronary Intervention
    Medical condition: Coronary heart disease with stable angina or non-ST elevation myocardial infarction (NSTEMI)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051592 Acute coronary syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002995-33 Sponsor Protocol Number: MU-707 901 Start Date*: 2007-09-18
    Sponsor Name:MUCOS Pharma GmbH Co. KG
    Full Title: Efficacy and safety of three dosages of Wobenzym mono in patients with acute rhinosinusitis Randomised, comparative, parallell group, placebo controlled, double-blind, multicentre, two phase adapti...
    Medical condition: Acute rhinosinusitis: with a rhinsinusitis symptom score >= 13 points (of maximal 25 points) using a 6 point-rating scala for the following symptoms which arose within up to 3 days prior to visit 1...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052106 Rhinosinusitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-017168-17 Sponsor Protocol Number: GS-US-270-0101 Start Date*: 2010-05-31
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled Study of Ranolazine in Patients with Heart Failure with Preserved Ejection Fraction
    Medical condition: Heart failure with Preserved Ejection Fraction
    Disease: Version SOC Term Classification Code Term Level
    12.1 10069211 Diastolic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-021789-31 Sponsor Protocol Number: A3051139 Start Date*: 2010-12-08
    Sponsor Name:Pfizer Inc.235 East 42nd Street, New York, NY 10017 US
    Full Title: A PHASE 4 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF RE-TREATMENT WITH VARENICLINE IN SUBJECTS WHO ARE CURRENTLY SMOKING, AND WHO HAVE PRE...
    Medical condition: Smoking Cessation
    Disease: Version SOC Term Classification Code Term Level
    15.0 10042613 - Surgical and medical procedures 10053325 Smoking cessation therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-021361-69 Sponsor Protocol Number: DC01/RUP/2/09 Start Date*: 2010-09-13
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: A multicenter, open-label study to assess pharmacokinetics, efficacy, tolerability and safety of Rupatadine in paediatrics patients (2-5 years old) with allergic rhinitis.
    Medical condition: Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10001723 Allergic rhinitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018370-21 Sponsor Protocol Number: C-II-007 Start Date*: 2010-05-27
    Sponsor Name:CESAR Central European Society for Anticancer Drug Research EWIV
    Full Title: Phase I/II study with Temsirolimus versus no add-on in patients with castration resistant prostate cancer (CRPC) receiving first-line Docetaxel chemotherapy CESAR Study in Prostrate Cancer wi...
    Medical condition: castration resistant prostate cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011980-35 Sponsor Protocol Number: 09PUK/DCsc05 Start Date*: 2009-08-03
    Sponsor Name:IBSA Institut Biochimique SA
    Full Title: Multicentre, randomised, double-blind (double-dummy), active comparator-controlled, phase III study of the efficacy and safety of a single s.c. Diclofenac HPBCD 75mg/1ml injection as compared to a ...
    Medical condition: acute moderate-to-severe post-surgical pain from dental surgery (impacted 3rd molar extraction)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10044049 Dental pain and sensation disorders HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2015-003929-34 Sponsor Protocol Number: AUT042063 Start Date*: 2016-03-10
    Sponsor Name:Autifony Therapeutics Limited
    Full Title: A Pilot Double-blind, Placebo-controlled Crossover Study to Explore the Possible Benefit of AUT00063, an Oral Modulator of Voltage-gated Potassium Channels, in Adult Post-lingual Unilateral Cochlea...
    Medical condition: Impaired speech understanding in users of cochlear implants
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10048812 Deafness unilateral PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000211-33 Sponsor Protocol Number: P02100 Start Date*: 2016-10-06
    Sponsor Name:Papworth Hospital NHS Foundation Trust
    Full Title: Dose Effect Relationship of a Single Dose of Rituximab on the Kinetics of B Lymphocytes in Patients with Acute ST-Segment Myocardial Infarction
    Medical condition: Anterior STEMI revascularised by PPCI
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10066641 Acute myocardial infarction, of anterior wall LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002784-91 Sponsor Protocol Number: HAW0501 Start Date*: 2006-02-06
    Sponsor Name:Cardiff and Vale NHS Trust
    Full Title: A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Dai...
    Medical condition: Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody d...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000914-37 Sponsor Protocol Number: NEU 1X Start Date*: 2004-08-12
    Sponsor Name:Neurim Pharmaceuticals (1991) Ltd
    Full Title: A DOUBLE-BLIND, PARALLEL GROUP, RANDOMISED, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CIRCADIN® 2MG IN THE IMPROVEMENT OF SLEEP QUALITY IN PATIENTS WITH INSOMNIA AGED 55-80 YEARS.
    Medical condition: Primary Insomnia in adults over 55 years
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-002831-14 Sponsor Protocol Number: CZOL446GDE13 Start Date*: 2005-06-09
    Sponsor Name:Novartis Pharma GmbH
    Full Title: Influence of Zoledronic acid (Zometa®) on bone mineral density and bone ultrasonometry in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment
    Medical condition: Primary, hormonreceptor negative breast cancer in premenopausal women
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002168-84 Sponsor Protocol Number: 839 Start Date*: 2008-01-07
    Sponsor Name:Kneipp-Werke
    Full Title: Wirksamkeit und Verträglichkeit von Kneipp Arnika Salbe S bei stumpfen Sportverletzungen im Vergleich zu Ibutop Creme (Efficacy and Safety of Kneipp Arnika Salbe S for blunt impact sport injuries c...
    Medical condition: Patients with blunt impact injuries (traumatic injuries)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10044528 Traumatic injury LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-014762-26 Sponsor Protocol Number: RDEA594-204 Start Date*: 2009-10-27
    Sponsor Name:Ardea Biosciences, Inc.
    Full Title: A Phase 2, Multiple-Dose, Pharmacokinetic and Pharmacodynamic Study of RDEA594 in Gout Patients with Hyperuricemia and Gout with Renal Insufficiency
    Medical condition: Gout.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10018627 Gout LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (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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