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Clinical trials for Ototoxicity

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   44335   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 ).  
     
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    22 result(s) found for: Ototoxicity. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-004463-44 Sponsor Protocol Number: CHUB-NAC Start Date*: 2020-01-22
    Sponsor Name:CHU Saint Pierre
    Full Title: Intratympanic injection of N-acetylcysteine for prevention of Cisplatine-induced ototoxicity
    Medical condition: Ototoxicity
    Disease: Version SOC Term Classification Code Term Level
    20.0 10013993 - Ear and labyrinth disorders 10033109 Ototoxicity PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003953-16 Sponsor Protocol Number: OTO4008 Start Date*: 2016-04-05
    Sponsor Name:ÁREA DE ATENCIÓN INTEGRADA DE ALBACETE
    Full Title: A Phase IIIb study of the efficacy of dexamethasone in irreversible hearing loss prevention in subjects with Ototoxic Oncological Treatment. Otoprotection in cancer treatment.
    Medical condition: Cisplatin ototoxicity
    Disease: Version SOC Term Classification Code Term Level
    18.1 10013993 - Ear and labyrinth disorders 10033109 Ototoxicity PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001509-25 Sponsor Protocol Number: RHMCAN0860 Start Date*: 2012-09-25
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: COAST - Cisplatin Ototoxicity attenuated by Aspirin Trial A randomised, Phase II, double-blind, placebo-controlled, two arm Trial to establish whether Aspirin can reduce hearing loss/ototoxicity fo...
    Medical condition: To establish whether Aspirin can reduce hearing loss/ototoxicity for patients receiving Cisplatin based chemotherapy.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10013993 - Ear and labyrinth disorders 10033109 Ototoxicity PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-002705-10 Sponsor Protocol Number: SENS-401-202 Start Date*: 2022-03-04
    Sponsor Name:SENSORION PHARMA
    Full Title: An Exploratory, Phase IIa, Multicenter, Randomized, Controlled, Open label Study to Evaluate the Efficacy of SENS-401 to Prevent or Treat the Ototoxicity due to Cisplatin in Adult Subjects with a N...
    Medical condition: Cisplatin-induced hearing loss
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-002402-21 Sponsor Protocol Number: RG_09-205 Start Date*: 2007-08-24
    Sponsor Name:University of Birmingham
    Full Title: A multi-centre open label randomised phase III trial of the efficacy of sodium thiosulphate in reducing ototoxicity in patients receiving cisplatin chemotherapy for standard risk hepatoblastoma
    Medical condition: Standard risk hepatoblatoma in children
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10019824 Hepatoblastoma resectable LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) FR (Ongoing) IE (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-001401-41 Sponsor Protocol Number: TAPAS-2014 Start Date*: 2014-07-29
    Sponsor Name:
    Full Title: Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis
    Medical condition: Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) IT (Completed)
    Trial results: (No results available)
    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: 2016-001784-36 Sponsor Protocol Number: PAED-201601 Start Date*: 2019-08-12
    Sponsor Name:Rheinische Friedrich-Wilhelms-Universität Bonn
    Full Title: Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin
    Medical condition: Extracranial germ cell tumours of any malignant histology, primary site and stage
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003696-19 Sponsor Protocol Number: E7080-G000-230 Start Date*: 2020-02-28
    Sponsor Name:Eisai Ltd
    Full Title: A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adoles...
    Medical condition: Relapsed or Refractory Osteosarcoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) AT (Completed) DE (Completed) FR (Completed) BE (Completed) IE (Completed) NL (Completed) IT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-006109-85 Sponsor Protocol Number: RTBAIEOP012 Start Date*: 2012-02-14
    Sponsor Name:A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
    Full Title: DIAGNOSTIC AND THERAPEUTIC STUDY FOR NEWLY DIAGNOSED RETINOBLASTOMA PATIENTS RTB AIEOP 012
    Medical condition: Newly diagnosed retinoblastoma patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10038916 Retinoblastoma PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-004838-37 Sponsor Protocol Number: AloCELYVIR Start Date*: 2021-04-19
    Sponsor Name:Fundación de Investigación Biomédica Hospital Niño Jesús
    Full Title: Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR (Mesenchymal allogenic cells + ICOVIR-5) in children, adolescent and young adults with newly diagn...
    Medical condition: Newly diagnosed Diffuse Intrinsic Pointine Glioma (DIPG) or Medulloblastoma in relapse/progression in children, adolescents and young adults.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066594 Medulloblastoma recurrent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10080666 Diffuse intrinsic pontine glioma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001840-83 Sponsor Protocol Number: SAGA Start Date*: 2022-04-26
    Sponsor Name:University Medical Center Utrecht
    Full Title: Short-course aminoglycosides as adjunctive treatment in adults with sepsis
    Medical condition: Patients admitted with sepsis of unknown origin, suspected urinary origin or suspected abdominal origin
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002996-36 Sponsor Protocol Number: 15TETE04 Start Date*: 2021-06-23
    Sponsor Name:INSTITUT CLAUDIUS REGAUD
    Full Title: A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTA0-Tyr3-Octreotate in Children with Refractory or Recurrent Neuroblastoma expressing som...
    Medical condition: Recurrent or refractory neuroblastoma.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066595 Neuroblastoma recurrent PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2023-000036-30 Sponsor Protocol Number: NBK151/1/2022 Start Date*: 2023-08-31
    Sponsor Name:Medical University of Gdańsk
    Full Title: A clinical trial in children and adolescents with primary malignant liver cancer - Hepatoblastoma and Hepatocarcinoma.
    Medical condition: Hepatoblastoma and liver cancer (hepatocarcinoma)
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004441-33 Sponsor Protocol Number: MK-7902-013(E7080-G000-231) Start Date*: 2020-07-10
    Sponsor Name:Merck Sharp & Dohme Corp.
    Full Title: An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Malignancies
    Medical condition: Relapsed/Refractory pediatric solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) FR (Trial now transitioned) SE (Completed) HU (Completed) Outside EU/EEA BE (Completed) IT (Trial now transitioned) ES (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2018-004141-17 Sponsor Protocol Number: Start Date*: 2020-08-07
    Sponsor Name:Children's Oncology Group
    Full Title: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
    Medical condition: Ovarian, Testicular, or Extragonadal germ cell tumours
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015800 Extragonadal primary germ cell tumour mixed stage I PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015801 Extragonadal primary germ cell tumour mixed stage II PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015802 Extragonadal primary germ cell tumour mixed stage III PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10043331 Testicular germ cell tumour mixed stage I PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10043332 Testicular germ cell tumour mixed stage II PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10043333 Testicular germ cell tumour mixed stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004433 Benign ovarian tumour PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006032 Borderline ovarian tumour PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-005039-94 Sponsor Protocol Number: IC2019-05 Start Date*: 2020-12-08
    Sponsor Name:Institut Curie
    Full Title: RETINO 2018 : Ocular conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome.
    Medical condition: Retinoblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000122-21 Sponsor Protocol Number: NVL-655-01 Start Date*: 2022-07-08
    Sponsor Name:Nuvalent, Inc.
    Full Title: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients with Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
    Medical condition: Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors with ALK rearrangement or activating ALK mutation.
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000533-13 Sponsor Protocol Number: Randomet2017 Start Date*: 2019-12-05
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH
    Full Title: Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, stan...
    Medical condition: Stage IV childhood renal tumours
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) CZ (Ongoing) DK (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004261-26 Sponsor Protocol Number: MM-398-01-03-04 Start Date*: 2018-10-29
    Sponsor Name:Ipsen Bioscience, Inc
    Full Title: RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based...
    Medical condition: Small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10041067 Small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) ES (Ongoing) HU (Completed) BE (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
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