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Clinical trials for Social ethics

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    40 result(s) found for: Social ethics. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2021-002247-30 Sponsor Protocol Number: RC31/21/0217 Start Date*: 2021-09-24
    Sponsor Name:CHU TOULOUSE
    Full Title: Evaluation of Amoxicillin diffusion in breast milk according to a population pharmacokinetic approach.
    Medical condition: Breastfeeding
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004193-64 Sponsor Protocol Number: RVP-30-001 Start Date*: 2022-06-29
    Sponsor Name:Reviva Pharmaceuticals Holdings Inc.
    Full Title: Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects with an Acute Exacerbation of Schizophrenia...
    Medical condition: Acute Exacerbation of Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001064 Acute schizophrenia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004152-20 Sponsor Protocol Number: AVA 102675 Start Date*: 2007-11-16
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-t...
    Medical condition: Mild-moderate Alzheimer disease
    Disease: Version SOC Term Classification Code Term Level
    6.1 10012271 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) SE (Prematurely Ended) BE (Completed) ES (Completed) GR (Prematurely Ended) FR (Completed) CZ (Prematurely Ended) AT (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended) FI (Prematurely Ended) SI (Prematurely Ended) HU (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended) SK (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002270-48 Sponsor Protocol Number: 31-14-204 Start Date*: 2019-01-31
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects with Tourette’s Disorder
    Medical condition: Tourette’s Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10044126 Tourette's disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-001589-13 Sponsor Protocol Number: N/A Start Date*: 2012-06-26
    Sponsor Name:Belfast Health and Social Care Trust
    Full Title: The effect of Aspirin on REducing iNflammation in human in vivo model of Acute lung injury (ARENA)
    Medical condition: The intended indication for the product under development is that of acute lung injury.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10069351 Acute lung injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2013-004246-41 Sponsor Protocol Number: RG_13-198 Start Date*: 2015-01-26
    Sponsor Name:Sandwell and West Birmingham Hospitals NHS Trust [...]
    1. Sandwell and West Birmingham Hospitals NHS Trust
    2. University of Birmingham
    Full Title: A phase III randomised study of folic acid supplementation in the management of menopausal symptoms in cancer survivors and healthy postmenopausal women
    Medical condition: Menopause Symptoms
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004872 10027311 Menopause flushing LLT
    18.0 10041244 - Social circumstances 10028812 Natural menopause LLT
    18.0 10041244 - Social circumstances 10027308 Menopause PT
    18.0 10041244 - Social circumstances 10051775 Postmenopause PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-004898-30 Sponsor Protocol Number: 191622-121 Start Date*: 2013-07-18
    Sponsor Name:Allergan Ltd
    Full Title: Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
    Medical condition: Urinary Incontinence due to Neurogenic Detrusor Overactivity
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) AT (Completed) IT (Completed) DE (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000868-42 Sponsor Protocol Number: B3461045 Start Date*: 2016-09-26
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, EXTENSION STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN SUBJECTS DIAGNOSED WITH TRANSTHYR...
    Medical condition: Transthyretin amyloid cardiomyopathy (TTR-CM)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10002020 Amyloid cardiomyopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) CZ (Completed) DE (Completed) SE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002726-84 Sponsor Protocol Number: SHP607-203 Start Date*: Information not available in EudraCT
    Sponsor Name:Premacure AB
    Full Title: Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003714-39 Sponsor Protocol Number: NBI-98854-ATS3019 Start Date*: 2022-07-14
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia
    Medical condition: Schizophrenia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005387-22 Sponsor Protocol Number: ACP-103-069 Start Date*: 2022-06-27
    Sponsor Name:Acadia Pharmaceuticals Inc.
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
    Medical condition: Treatment of irritability associated with autistic disorder in children and adolescents with ASD
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10063844 Autism spectrum disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) HU (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011424-64 Sponsor Protocol Number: M10-984 Start Date*: 2009-11-09
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease
    Medical condition: Mild to moderate Alzheimer's Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) SK (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-003488-23 Sponsor Protocol Number: 31-12-293 Start Date*: 2013-01-30
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder
    Medical condition: Tics associated with Tourette’s Disorder in children and adolescents
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10044126 Tourette's disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) FI (Prematurely Ended) BE (Completed) SE (Completed) ES (Prematurely Ended) GB (Completed) IT (Completed) DE (Prematurely Ended) NL (Not Authorised) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003708-29 Sponsor Protocol Number: B7981005 Start Date*: 2017-04-18
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe...
    Medical condition: Moderate to severe Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) LT (Completed) DK (Completed) DE (Completed) AT (Completed) PL (Completed) HU (Completed) ES (Completed) NL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001306-41 Sponsor Protocol Number: ALD403-CLIN-011 Start Date*: 2017-04-27
    Sponsor Name:Alder BioPharmaceuticals, Inc.
    Full Title: A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine
    Medical condition: Chronic Migraine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10027599 Migraine PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DK (Completed) DE (Completed) BE (Completed) SK (Completed) HU (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-006070-22 Sponsor Protocol Number: A0221007 Start Date*: 2007-03-16
    Sponsor Name:Pfizer Inc
    Full Title: A 12-WEEK, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE EFFECTS OF FESOTERODINE ON TREATMENT SATISFACTION AND SYMPTOM RELIEF IN OVERACTIVE BLADDER PATIENTS
    Medical condition: Overactive bladder (OAB) is a symptom complex defined by the International Continence Society (ICS) as the symptoms of urgency, with or without urgency incontinence, usually with frequency and noct...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10059617 Overactive bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SK (Completed) CZ (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004800-40 Sponsor Protocol Number: AT1001-041 Start Date*: 2012-01-25
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease.
    Medical condition: Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme α-galactosidase A.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed) DK (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000550-12 Sponsor Protocol Number: 2014-PT026 Start Date*: 2014-07-23
    Sponsor Name:XBiotech Germany GmbH
    Full Title: A Double Blind, Placebo Controlled, Pivotal Phase III Study Evaluating Xilonix™ in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy
    Medical condition: Symptomatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) PL (Completed) DE (Prematurely Ended) CZ (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-004036-36 Sponsor Protocol Number: 178-MA-1008 Start Date*: 2016-07-18
    Sponsor Name:Astellas Pharma Global development, Inc
    Full Title: A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi- Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While ...
    Medical condition: Over active bladder (OAB) in men with Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10046543 Urinary incontinence PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) DE (Completed) PL (Completed) ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000468-83 Sponsor Protocol Number: 31-10-273 Start Date*: 2011-12-15
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents with Tourette’s Disorder
    Medical condition: Tourette’s Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10044126 Tourette's disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BG (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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