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Clinical trials for Robustness

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    24 result(s) found for: Robustness. Displaying page 1 of 2.
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    EudraCT Number: 2007-006217-16 Sponsor Protocol Number: AGO/2007/012 Start Date*: 2007-12-14
    Sponsor Name:University Hospital Ghent
    Full Title: Evaluation of the accuracy, safety and robustness of a single-input-single output (SISO) model-based predictive closed-loop system to guide patient-individualized ICU sedation.
    Medical condition: Patients entering the post-operative cardiac intensive care unit following coronary artery reconstruction surgery (OPCAB)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001089-90 Sponsor Protocol Number: OTT329/402 Start Date*: Information not available in EudraCT
    Sponsor Name:Oriel Therapeutics, a Sandoz Company
    Full Title: Study to Test the Product Robustness of a Dry Powder Inhalation Device When Used in Normal Clinical Practice with Young Asthma Patients
    Medical condition: The study is designed to demonstrate the robustness of the OT329 Solis product. The primary endpoint that is derived from the dataset will be product robustness after approximately 21-24 days of ...
    Disease: Version SOC Term Classification Code Term Level
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003561 Asthma, unspecified LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2006-004582-33 Sponsor Protocol Number: VR040/2/002 Start Date*: 2006-11-03
    Sponsor Name:Vectura Group plc
    Full Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable “Off” or End-of-Dose “Wearing ...
    Medical condition: Hypomobility (off or freezing) episodes associated with advanced Parkinson's disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003474-86 Sponsor Protocol Number: NCT0023595 Start Date*: 2011-12-12
    Sponsor Name:Myron D. Ginsberg
    Full Title: Albumin in Acute Stroke (ALIAS) Trial-Part 2: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke
    Medical condition: Acute Ischemic Stroke
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000463-13 Sponsor Protocol Number: MGR001-1010 Start Date*: 2015-05-05
    Sponsor Name:Mylan Pharma UK Ltd
    Full Title: AN OPEN STUDY TO ASSESS THE ROBUSTNESS OF THE CRC749 DEVICE BY PHARMACEUTICAL PERFORMANCE FOLLOWING TWICE DAILY DOSING OF MGR001 ADMINISTERED VIA ORAL INHALATION IN SUBJECTS WITH ASTHMA OR CHRONIC ...
    Medical condition: Asthma or chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-005476-32 Sponsor Protocol Number: VR004/008 Start Date*: 2006-02-02
    Sponsor Name:Vectura Group plc
    Full Title: A Phase IIb, Randomised, Double-Blind, Placebo Controlled, Dose Finding Study Assessing the Haemodynamic Safety and "At Home" Efficacy of Inhaled VR004 in patients with Erectile Dysfunction (ED).
    Medical condition: Erectile dysfunction
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-001592-20 Sponsor Protocol Number: 91710346.2.1 Start Date*: 2013-07-25
    Sponsor Name:
    Full Title: Pilot study for studying the influence of low-dose propofol on the classification of movements from the electroencephalogram in healthy participants
    Medical condition: Intraoperative awareness during general anesthesia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-000574-40 Sponsor Protocol Number: PSP-CoQ10 Start Date*: 2006-04-24
    Sponsor Name:Kompetenznetz Parkinson e.V.
    Full Title: Brain Energy Metabolism in Progressive Supranuclear Palsy: Comparison of PSP Patients and Healthy Controls and Effect of Coenzyme Q10 – nanoQuinon®
    Medical condition: PSP is a sporadic neurodegenerative disorder resulting in a Parkinson syndrome with postural instability, oculomotor deficits, and cognitive decline. With an average annual incidence of 5.3 / 10...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003158-15 Sponsor Protocol Number: GA1406 Start Date*: 2014-10-10
    Sponsor Name:Reckitt Benckiser Healthcare (UK) Limited
    Full Title: A randomised, assessor blind, placebo controlled exploratory study in healthy volunteers, to characterise the acid neutralisation activity of sodium alginate oral suspension in the fasted state, us...
    Medical condition: To pilot the use of a custom designed pH catheter for the measurement of intragastric pH to characterise the antacid action of Gaviscon Double Action versus placebo.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2004-000478-30 Sponsor Protocol Number: AC-052-364 Start Date*: 2004-10-28
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in pat...
    Medical condition: Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. T...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) ES (Completed) CZ (Completed) GB (Completed) BE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002918-43 Sponsor Protocol Number: CNTO1275CRD3005 Start Date*: 2017-02-28
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab
    Medical condition: Moderately to severely active Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) ES (Ongoing) BE (Completed) DE (Completed) NL (Completed) FR (Completed) PT (Completed) SK (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001583-29 Sponsor Protocol Number: Er-02-Perf-AD Start Date*: 2012-10-18
    Sponsor Name:University Hospital Erlangen
    Full Title: Prospective, open-label, two-arm, parallel-group, single center phase IV clinical trial to evaluate the diagnostic value of a Gadobutrol enhanced dynamic susceptibility perfusion MRI (DSC-MRP) and ...
    Medical condition: Patients with dementing disorders, namely minor alzheimers disease or subjects with mild cognitive impairment and normal controls
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-005932-10 Sponsor Protocol Number: NCTU:ISRCTN50395346 Start Date*: 2009-03-30
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: A double-blind randomised multi-centre, placebo-controlled trial of combined ACE-inhibitor and beta-blocker therapy in preventing the development of cardiomyopathy in genetically characterised male...
    Medical condition: Duchenne muscular dystrophy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013801 Duchenne muscular dystrophy LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002446-76 Sponsor Protocol Number: DCC-2618-03-001 Start Date*: 2018-03-29
    Sponsor Name:Deciphera Pharmaceuticals, LLC
    Full Title: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients with AdvanCed Gastrointestinal Stromal TUmorS who have Received Treatment...
    Medical condition: Patients with AdvanCed Gastrointestinal Stromal TUmorS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) NL (Prematurely Ended) BE (Completed) ES (Prematurely Ended) PL (Prematurely Ended) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002333-19 Sponsor Protocol Number: OMS112831 Start Date*: 2011-11-29
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-...
    Medical condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029205 - Nervous system disorders 10070716 Multiple sclerosis pseudo relapse LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed) DK (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-001612-20 Sponsor Protocol Number: ML21445 Start Date*: 2008-05-29
    Sponsor Name:ROCHE
    Full Title: A study of chlorambucil plus MabThera as induction therapy followed in responders by maintenance therapy versus observation on response rate in patients ≥ 60 years with previously untreated ...
    Medical condition: CD20+ CLL, Binet stage C or Binet stages A-B
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008956 Chronic lymphatic leukaemia LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005558-21 Sponsor Protocol Number: LUM001-401 Start Date*: 2015-03-25
    Sponsor Name:Lumena Pharmaceuticals LLC
    Full Title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Sclerosing Cholan...
    Medical condition: Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease of unknown aetiology. PSC is characterized by inflammation and fibrosis of the intra- and extrahepatic biliary tree re...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-003229-27 Sponsor Protocol Number: ImPRESS Start Date*: 2019-06-04
    Sponsor Name:Oslo University Hospital
    Full Title: ImPRESS - Imaging Perfusion Restrictions from Extracellular Solid Stress - An open-label losartan study
    Medical condition: Patients with newly diagnosed or recurrent glioblastomas Patients with brain metastases from non-small-cell lung cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005151-83 Sponsor Protocol Number: MUCUS Start Date*: 2018-10-26
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-005216-21 Sponsor Protocol Number: IFM2020-02 Start Date*: 2021-08-30
    Sponsor Name:Intergroupe Francophone du Myélome
    Full Title: MInimal residual Disease Adapted Strategy: frontline therapy for patients eligible for autologous stem cell transplantation less than 66 years; a prospective study from the French cooperative group...
    Medical condition: Patients with multiple myeloma, newly diagnosed and eligible for autologous stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned)
    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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