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Clinical trials for Intravesical Drug Administration

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    16 result(s) found for: Intravesical Drug Administration. Displaying page 1 of 1.
    EudraCT Number: 2016-004269-14 Sponsor Protocol Number: HP002-001 Start Date*: 2018-05-07
    Sponsor Name:Hamlet Pharma AB
    Full Title: A Randomized Placebo controlled Phase I/II Study Evaluating the Safety and Efficacy of Alpha1H in adult patients with non-muscle invasive bladder cancer awaiting transurethral surgery
    Medical condition: Non-muscle invasive bladder cancer awaiting transurethral surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-004112-28 Sponsor Protocol Number: URO-EMDA-2022-1 Start Date*: 2023-03-27
    Sponsor Name:Guillem Abad Carratalà
    Full Title: Randomized prospective study of the impact of preoperative instillation of mitomycin-C by electromotive drug administration (EMDA) in patients with non-muscle-infiltrating urothelial carcinoma
    Medical condition: Non muscle invasive bladder tumor
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005009 Bladder cancer stage I, without cancer in situ PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012274-13 Sponsor Protocol Number: R39-09-01 Start Date*: 2009-09-17
    Sponsor Name:FIDIA
    Full Title: ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study
    Medical condition: Patients affected by multiple recurrent Ta G1-G2 papillary cancer of the bladder.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10005003 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000905-19 Sponsor Protocol Number: Rec0/0438-IT-CL0491 Start Date*: 2018-01-29
    Sponsor Name:Recordati S.p.A
    Full Title: EFFECTS OF TWO DIFFERENT DOSES OF REC 0/0438 ADMINISTERED BY INTRA-VESICAL INSTILLATION IN PATIENTS WITH NEUROGENIC DETRUSOR OVERACTIVITY DUE TO SPINAL CORD INJURY: A REPEATED DOSES, DOUBLE-BLIND,...
    Medical condition: neurogenic detrusor overactivity due to spinal cord injury
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10005059 Bladder neurogenic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Completed) PL (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-002449-39 Sponsor Protocol Number: 42756493BLC2003 Start Date*: 2020-07-10
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Inva...
    Medical condition: Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusions Cohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) GB (GB - no longer in EU/EEA) ES (Temporarily Halted) PL (Trial now transitioned) BE (Completed) FR (Trial now transitioned) CZ (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003055-40 Sponsor Protocol Number: SON-8184-1073 Start Date*: 2005-08-23
    Sponsor Name:SONUS Pharmaceuticals Inc.
    Full Title: A PHASE 2 MULTICENTER EVALUATION OF THE SAFETY AND EFFICACY OF TOCOSOL ® PACLITAXEL (S-8184 PACLITAXEL INJECTABLE EMULSION) IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED, UNRESECTABLE TRANSITIONA...
    Medical condition: PATIENTS WITH METASTATIC OR LOCALLY ADVANCED, UNRESECTABLE TRANSITIONAL CELL CARCINOMA OF THE UROTHELIUM
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003626-40 Sponsor Protocol Number: CA209-274 Start Date*: 2016-07-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma
    Medical condition: Subjects with High Risk Invasive Urothelial Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) AT (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) SE (Trial now transitioned) PL (Trial now transitioned) IE (Trial now transitioned) GB (GB - no longer in EU/EEA) GR (Trial now transitioned) RO (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001013-81 Sponsor Protocol Number: ProBaBle Start Date*: 2014-10-10
    Sponsor Name:Centro Hospitalar de São João, EPE
    Full Title: Treatment of Bladder Pain Syndrome with Onabotulinum toxin A
    Medical condition: Bladder Pain Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10071166 Bladder pain syndrome LLT
    Population Age: Adults Gender: Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001650-26 Sponsor Protocol Number: AnticholiumperSeIII Start Date*: 2014-04-28
    Sponsor Name:Ruprecht-Karls-University Heidelberg, Med Faculty represented by Universitätsklinikum Heidelberg and its Commercial D
    Full Title: A randomised, placebo-controlled, double-blind, monocentre study on the application of physostigminsalicylate (Anticholium®) as adjunctive measure in perioperative sepsis/septic shock
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000309-21 Sponsor Protocol Number: UCa-001 Start Date*: 2018-10-31
    Sponsor Name:Inovio Pharmaceuticals, Inc.
    Full Title: An Open-Label, Multi-Center Trial of INO-5401 + INO-9012 in Combination with Atezolizumab in Subjects with Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
    Medical condition: Locally advanced unresectable or metastatic/recurrent Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10077056 Urothelial carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001947-28 Sponsor Protocol Number: T2017-002 Start Date*: 2019-06-11
    Sponsor Name:Therapeutic Advances in Childhood Leukemia Consortium (TACL)
    Full Title: A TACL Phase 1/2 Study of PO Ixazomib in Combination with Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
    Medical condition: Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LLy)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000845 Acute lymphoblastic leukemia LLT
    20.0 100000004864 10065923 Lymphoblastic lymphoma LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-000205-24 Sponsor Protocol Number: G1T28-209 Start Date*: 2021-10-28
    Sponsor Name:G1 Therapeutics, Inc.
    Full Title: A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered with First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients with Untreated, Locally Advanced or Meta...
    Medical condition: Untreated, Locally Advanced or Metastatic Urothelial Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005565-13 Sponsor Protocol Number: 17000139BLC2002 Start Date*: 2021-10-26
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are...
    Medical condition: Muscle-Invasive Urothelial Carcinoma of the Bladder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    21.0 100000004864 10046720 Urothelial carcinoma bladder stage II LLT
    21.0 100000004864 10046721 Urothelial carcinoma bladder stage III LLT
    21.0 100000004864 10046722 Urothelial carcinoma bladder stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003471-30 Sponsor Protocol Number: D-FR-52120-222 Start Date*: 2016-09-26
    Sponsor Name:Ipsen Innovation
    Full Title: A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT...
    Medical condition: Urinary incontinence (UI) caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
    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, Female
    Trial protocol: RO (Completed) PT (Completed) CZ (Completed) IT (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-000117-34 Sponsor Protocol Number: Nordic VII Start Date*: 2005-04-22
    Sponsor Name:The Nordic Colorectal Cancer Biomodulation Group
    Full Title: Combination of 5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin®) (FLOX regimen) with Concomitant or Concomitant and Maintenance Administration of Cetuximab (Erbitux®), in First-Line Treatment of Meta...
    Medical condition: Patient with metastatic colorectal cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) IS (Completed) FI (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-000507-44 Sponsor Protocol Number: D-FR-52120-223 Start Date*: 2016-06-29
    Sponsor Name:Ipsen Innovation
    Full Title: A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONE OR MORE INTRADETRUSOR TREATMENTS OF 600 OR 800 UNITS OF DYSPORT...
    Medical condition: Urinary incontinence caused by neurogenic detrusor overactivity due to either spinal cord injury or multiple sclerosis
    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, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FR (Completed) LT (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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