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Clinical trials for Internal validity

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    10 result(s) found for: Internal validity. Displaying page 1 of 1.
    EudraCT Number: 2012-005723-33 Sponsor Protocol Number: amantadineSCEDI. Start Date*: 2015-03-27
    Sponsor Name:GGZ Oost Brabant
    Full Title: Efficacy of amantadine on behavioural and emotional problems and impairment of executive functioning due to acquired brain injury to the frontal lobes: a series of single case experimental design s...
    Medical condition: behavioural and emotional problems and impairment of executive functioning due to acquired brain injury to the frontal lobes
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-004579-37 Sponsor Protocol Number: MZ12-PCP-PalenicekTomas-A Start Date*: 2014-06-18
    Sponsor Name:National Institute of Mental Health
    Full Title: Animal and human serotonergic model of schizophrenia: validity evaluated by qEEG and fMRI
    Medical condition: Inclusion criteria: a) Men and women at age between 28 and 65 years b) healthy volunteers with negative psychiatric history (severe mental illnesses that meet the criteria of ICD 10 F0.X - F99.X) ...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001101-14 Sponsor Protocol Number: 750253.01.030 Start Date*: 2016-03-09
    Sponsor Name:Dr. Willmar Schwabe GmbH & Co. KG
    Full Title: Driving fitness under acute and subchronic application of Silexan® (WS® 1265) in comparison to placebo and Lorazepam with healthy volunteers in two successive, randomized, double-blind, crossover d...
    Medical condition: Investigation in healthy volunteers. The investigational medicinal product has a marketing authorisation in Germany for the treatment of restlessness related to anxious mood.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-002544-25 Sponsor Protocol Number: CL_700_002_PRO-AME3 Start Date*: 2006-01-02
    Sponsor Name:LAB Pharma Ltd
    Full Title: A Multicentre, Multinational, Open-Label Trial (including Double-Blind, Placebo-Controlled Cross-Over Extension Part) to Evaluate the Time to Significant Pain Relief with Fentanyl TAIFUN® in the Tr...
    Medical condition: Patients with cancer having episodes of breakthrough pain
    Disease: Version SOC Term Classification Code Term Level
    7.1 10058019 canc
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002545-42 Sponsor Protocol Number: INS-415 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous M...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) HU (Completed) AT (Completed) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-005144-16 Sponsor Protocol Number: MRZ 90001-AD-3001 Start Date*: 2008-11-26
    Sponsor Name:Merz Pharmaceuticals GmbH
    Full Title: Open-label, single-arm, multi-center validation study of the ROSA-Scale (Relevant Outcome Scale for Alzheimer Patients) in patients with dementia of Alzheimer’s type (DAT) treated with memantine ov...
    Medical condition: Dementia of Alzheimer's Type (DAT) of all severity stages
    Disease: Version SOC Term Classification Code Term Level
    11.0 10012271 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003766-27 Sponsor Protocol Number: 848015011 Start Date*: 2018-07-18
    Sponsor Name:VU University Medical Centre
    Full Title: The DREAMING study: Efficacy of low dose amitriptyline and mirtazapine for insomnia disorder: a double-blind, randomized, placebo-controlled trial in general practice
    Medical condition: Insonnia disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10078083 Insomnia disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-003032-31 Sponsor Protocol Number: P-110880-01 Start Date*: 2012-02-22
    Sponsor Name:Ferrer Internacional, S.A.
    Full Title: A phase III 3 arms, multicenter, randomised, investigator-blind study to assess the efficacy and safety of ozenoxacin 1% cream applied twice daily for 5 days versus placebo in the treatment of pati...
    Medical condition: Impetigo
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021531 Impetigo PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002226-23 Sponsor Protocol Number: 2013-002226-23 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Bergen, Department of Global Public Health and Primary Care
    Full Title: Efficacy of Pain Treatment on Depression in Patients with Dementia. A Randomized Clinical Trial of Efficacy
    Medical condition: Depression Pain Dementia
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005734-20 Sponsor Protocol Number: R076477-SCA-3002 Start Date*: 2008-04-24
    Sponsor Name:Janssen L.P.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Flexible Dose Paliperidone ER in the Treatment of Subjects with Schizoaffective Disorder
    Medical condition: Schizoaffective disorder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039621 Schizoaffective disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (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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