Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Drug labeling

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   44347   clinical trials with a EudraCT protocol, of which   7375   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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    50 result(s) found for: Drug labeling. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2021-003514-39 Sponsor Protocol Number: GNCbumet Start Date*: Information not available in EudraCT
    Sponsor Name:Gillberg Neuropsychiatry Centre
    Full Title: Testing E/I imbalance in autism with Bumetanide – a parallel group randomized waitlist-control trial in adolescents and adults
    Medical condition: Autism Spectrum Disorder
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-000799-33 Sponsor Protocol Number: 001 Start Date*: 2007-06-22
    Sponsor Name:Universitätsklinikum Essen
    Full Title: A Study of the efficacy and safety of Rizatriptan 10 mg PRD in the treatment of acute migraine in patients with non satisfactory response to previous pharmacologic treatment
    Medical condition: acute migraine
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-002261-37 Sponsor Protocol Number: OHB103755 Start Date*: 2005-08-01
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of Radafaxine Extended-Release (100-140mg/day) Com...
    Medical condition: Major Depressive Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FI (Completed)
    Trial results: View results
    EudraCT Number: 2005-003401-87 Sponsor Protocol Number: SND103285 Start Date*: 2006-02-15
    Sponsor Name:GlaxoSmithKline Research & Development
    Full Title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10025453 Major depressive disorder NOS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) BE (Completed) FR (Completed) EE (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002770-43 Sponsor Protocol Number: CUN-OMAL-UCOL Start Date*: 2013-10-28
    Sponsor Name:Clínica Universidad de Navarra/Universidad de Navarra
    Full Title: Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.
    Medical condition: Cholinergic urticaria
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-005246-38 Sponsor Protocol Number: 143660 Start Date*: 2013-05-13
    Sponsor Name:University of Oslo
    Full Title: The effects of methylphenidate on brain processes for decision making in adult attention deficit hyperactivity disorder
    Medical condition: Attention deficit hyperactivty disorder
    Disease: Version SOC Term Classification Code Term Level
    15.1 10037175 - Psychiatric disorders 10003736 Attention deficit/hyperactivity disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005234-21 Sponsor Protocol Number: P04843 Start Date*: 2007-11-28
    Sponsor Name:Schering-Plough Research Institute
    Full Title: A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.
    Medical condition: Opioid dependance
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013663 Drug dependence LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) SE (Completed) PT (Completed) DK (Completed) LT (Completed) SI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004672-20 Sponsor Protocol Number: SYR-322-OLE-012 Start Date*: 2006-04-24
    Sponsor Name:Takeda Global Research & Development Center, Inc.,
    Full Title: A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects with Type 2 Diabetes
    Medical condition: Type II diabetes mellitus.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) EE (Completed) SK (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2007-004993-15 Sponsor Protocol Number: MV21371 Start Date*: 2008-03-07
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Randomized, Open-Label, Multicenter Study Examining the Effects of 24 Versus 48 Weeks of Combination Therapy with PEGASYS® (Peginterferon alfa-2a 40KD) plus COPEGUS® (Ribavirin) on Sustained Vi...
    Medical condition: Chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001141-14 Sponsor Protocol Number: GV28855 Start Date*: 2013-10-01
    Sponsor Name:F.Hoffmann-La Roche Ltd.
    Full Title: A PHASE 4, BLOOD SAMPLE COLLECTION STUDY FOR EXPLORATORY EVALUATION OF THE ASSOCIATION OF SINGLE NUCLEOTIDE POLYMORPHISMS WITH TREATMENT RESPONSES FROM SUBJECTS WITH HBEANTIGEN POSITIVE OR NEGATIV...
    Medical condition: Chronic liver disease caused by the hepatitis B virus.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) BG (Completed) IT (Completed) GR (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-020004-30 Sponsor Protocol Number: A3921080 Start Date*: 2010-10-05
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, MULTI SITE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 AND 1 SUBCUTANEOUS DOSE OF ETANERCEPT IN SUBJECTS ...
    Medical condition: Moderate to Severe Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) CZ (Completed) ES (Completed) HU (Completed) NL (Completed) SK (Completed) BG (Completed) AT (Completed) PT (Completed) BE (Completed) DK (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000335-11 Sponsor Protocol Number: 8669-064 Start Date*: 2012-06-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2 Randomized Trial of the Combination of Ridaforolimus and Exemestane, Compared to Ridaforolimus, Dalotuzumab and Exemestane in High Proliferation, Estrogen Receptor Positive Breast Cancer ...
    Medical condition: ER positive, high proliferation breast
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) SE (Completed) CZ (Completed) BE (Completed) PT (Completed) DE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-003400-11 Sponsor Protocol Number: SND103288 Start Date*: 2005-11-09
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An Eight-week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group, Fixed-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.0 mg/day) or ...
    Medical condition: Major Depressive Disorder (MDD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) EE (Prematurely Ended) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004486-27 Sponsor Protocol Number: X31005 Start Date*: 2018-02-12
    Sponsor Name:Associació Per a la Recerca Oncològica(APRO)
    Full Title: Phase II Study of Paclitaxel and TAK-228 in metastatic urothelial carcinoma (UC) and the impact of PI3K-mTOR pathway genomic alterations
    Medical condition: Metastatic urothelial carcinoma (UC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004293-10 Sponsor Protocol Number: IM011084 Start Date*: 2019-07-22
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects with Active Psoriatic Arthritis (PsA)
    Medical condition: Psoriatic Arthritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10037160 Psoriatic arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) HU (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000667-24 Sponsor Protocol Number: 20120104 Start Date*: 2012-06-26
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: A...
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BE (Completed) HU (Completed) GR (Prematurely Ended) LV (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000651-13 Sponsor Protocol Number: 20120102 Start Date*: 2012-06-27
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1
    Medical condition: Moderate to severe plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-000064-21 Sponsor Protocol Number: TPN-101-AGS-201 Start Date*: 2022-09-20
    Sponsor Name:Transposon Therapeutics Inc
    Full Title: A Phase 2a Study of TPN-101 in Patients with Aicardi-Goutières Syndrome (AGS)
    Medical condition: Aicardi-Goutières Syndrome (AGS)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10010331 - Congenital, familial and genetic disorders 10083189 Aicardi-Goutieres syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002133-22 Sponsor Protocol Number: C31005 Start Date*: 2016-05-29
    Sponsor Name:Millenium Pharmaceuticals, a wholly owned subsidiary of Takeda pharmaceutical Company Limited
    Full Title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advan...
    Medical condition: metastatic clear-cell renal cell carcinoma (mccRCC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10050018 Renal cancer metastatic PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038407 Renal cell cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) PL (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001534-18 Sponsor Protocol Number: Aes-103-003 Start Date*: 2013-08-07
    Sponsor Name:AesRx
    Full Title: A Phase 2, Exploratory, Placebo-Controlled, Multicenter, Double-Blind Evaluation of the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Five Dose Regimens of Aes-103 Given for 2...
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10040644 Sickle cell disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Jul 06 13:35:21 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA