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Clinical trials for Estimated Average Requirement

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    14 result(s) found for: Estimated Average Requirement. Displaying page 1 of 1.
    EudraCT Number: 2014-001948-37 Sponsor Protocol Number: 3344 Start Date*: 2014-10-30
    Sponsor Name:North Bristol NHS Trust
    Full Title: Intramuscular oxytocics: A multi-centre randomised comparison study of intramuscular Carbetocin, Syntocinon and Syntometrine for the third stage of labour following vaginal birth
    Medical condition: Post partum haemorrhage
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002069-52 Sponsor Protocol Number: 4045-301 Start Date*: 2017-01-23
    Sponsor Name:Sarepta Therapeutics, Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy
    Medical condition: Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53 Skipping
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) SE (Completed) DE (Completed) FR (Ongoing) ES (Ongoing) CZ (Ongoing) NL (Ongoing) IT (Ongoing) BG (Ongoing) PL (Ongoing) IE (Ongoing) DK (Ongoing) GR (Ongoing) NO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000186-36 Sponsor Protocol Number: IB2017-04 Start Date*: 2019-01-07
    Sponsor Name:Institut Bergonié
    Full Title: Phase III trial investigating the potential benefit of intensified peri-operative Chemotherapy in patients with in high-risk CINSARC patients with resectable soft-tissue SARComas
    Medical condition: Resectable, non-metastatic soft-tissue sarcoma (STS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10039494 Sarcoma NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015579-28 Sponsor Protocol Number: FER-CKD-01 Start Date*: 2009-12-22
    Sponsor Name:Vifor Pharma Inc.
    Full Title: An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Ir...
    Medical condition: Iron deficiency anaemia in subjects with non-dialysis-dependent chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10022972 Iron deficiency anaemia PT
    14.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) SE (Completed) FR (Completed) DE (Completed) DK (Completed) ES (Completed) IT (Completed) CZ (Completed) AT (Completed) GR (Completed) PT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-002320-33 Sponsor Protocol Number: GRC17536-203 Start Date*: 2012-09-27
    Sponsor Name:Glenmark Pharmaceuticals SA
    Full Title: A Phase 2, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Pe...
    Medical condition: Pain associated with diabetic peripheral neuropathy (DPN).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10012683 Diabetic peripheral neuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2020-002966-15 Sponsor Protocol Number: LDX0419 Start Date*: 2021-02-22
    Sponsor Name:Dompe farmaceutici s.p.a.
    Full Title: A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and pres...
    Medical condition: New-onset Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001926-71 Sponsor Protocol Number: LDX0319 Start Date*: Information not available in EudraCT
    Sponsor Name:Dompe farmaceutici s.p.a.
    Full Title: A phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the effect and safety of 400 mg twice a day oral ladarixin in patients with recent onset type 1 diabetes and a l...
    Medical condition: Recent onset Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) SI (Ongoing) BE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015850-39 Sponsor Protocol Number: ADS-TCAD-PO206 Start Date*: 2009-11-12
    Sponsor Name:Adamas Pharmaceuticals, Inc
    Full Title: A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir to Influenza A Virus Infected I...
    Medical condition: Influenza A Virus
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002393-27 Sponsor Protocol Number: TL895201 Start Date*: 2021-05-28
    Sponsor Name:Telios Pharma, Inc.
    Full Title: A Phase 2, Multicenter Study of TL-895 in Subjects with Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis...
    Medical condition: Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, Indolent Systemic Mastocytosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10056452 Indolent systemic mastocytosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) HU (Completed) BE (Ongoing) BG (Ongoing) PL (Ongoing) IT (Ongoing) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003659-40 Sponsor Protocol Number: CNS-201 Start Date*: 2022-01-03
    Sponsor Name:CNS Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multifor...
    Medical condition: Glioblastoma Multiforme (WHO Grade IV)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005879-16 Sponsor Protocol Number: GRC17536-201 Start Date*: 2012-06-11
    Sponsor Name:Glenmark Pharmaceuticals SA
    Full Title: A Phase II, 4 Week Randomized, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic N...
    Medical condition: Pain associated with diabetic peripheral neuropathy (DPN).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10012683 Diabetic peripheral neuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001929-32 Sponsor Protocol Number: 2014/2126 Start Date*: 2016-01-21
    Sponsor Name:Gustave Roussy
    Full Title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication
    Medical condition: Diffuse Intrinsic Pontine Glioma and Diffuse midline glioma, K27M mutant
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006143 Brain stem glioma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Ongoing) SE (Ongoing) GB (GB - no longer in EU/EEA) NL (Ongoing) ES (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2018-000770-29 Sponsor Protocol Number: Ireland-RctV8 Start Date*: 2018-06-18
    Sponsor Name:The Rotunda Hospital
    Full Title: Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diab...
    Medical condition: Pregestational type I or type II diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045228 Type I diabetes mellitus LLT
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003734-32 Sponsor Protocol Number: BXCL701-201 Start Date*: 2019-07-02
    Sponsor Name:BioXcel Therapeutics, Inc
    Full Title: A Phase 1b/2 Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPP), Administered in Combination with the Anti-Programmed Cell Death 1 (PD-1) Monoclonal Antibody Pembrolizumab ...
    Medical condition: Small Cell Neuroendocrine Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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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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