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Clinical trials for Drug Efficacy Study Implementation

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    24 result(s) found for: Drug Efficacy Study Implementation. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-000424-19 Sponsor Protocol Number: 213199 Start Date*: 2020-09-07
    Sponsor Name:Viiv Healthcare UK Limited
    Full Title: A Phase IIIb, open-label, hybrid type III trial evaluating implementation strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in HIV-1 infected, virologically su...
    Medical condition: Human Immunodeficiency Virus Type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10003582 Asymptomatic human immunodeficiency virus type I infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003118-42 Sponsor Protocol Number: BAY88-8223/16507 Start Date*: 2014-08-08
    Sponsor Name:Bayer AG
    Full Title: A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) versus 80 kBq/kg (88 kBq/kg after implementation of NIST update)...
    Medical condition: Castration resistant prostate cancer with bone metastasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) SE (Completed) FI (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003827-38 Sponsor Protocol Number: CL004_282 Start Date*: 2006-05-02
    Sponsor Name:ChemoCentryx, Inc
    Full Title: A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease
    Medical condition: Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small or large bowel disease, with or without colonic disease. Their screening Crohn´s Disease ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) CZ (Completed) DE (Completed) HU (Completed) BG (Completed) SE (Completed) FR (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005385-38 Sponsor Protocol Number: GFT505-315-1 Start Date*: 2016-03-04
    Sponsor Name:Genfit SA
    Full Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis.
    Medical condition: Non-Alcoholic Steatohepatitis (NASH) and fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10018065 - General disorders and administration site conditions 10016642 Fibrosis PT
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Completed) DE (Completed) CZ (Prematurely Ended) SE (Completed) IT (Prematurely Ended) PT (Completed) NL (Completed) DK (Prematurely Ended) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001402-41 Sponsor Protocol Number: GS-US-296-2013 Start Date*: 2017-01-31
    Sponsor Name:Gilead Sciences, Inc
    Full Title: A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined with Nivolumab versus Nivolumab Alone in Subjects with Unresectable or Recurrent Gastric or Gastroeso...
    Medical condition: unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017761 Gastric cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) GB (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001526-42 Sponsor Protocol Number: GS-US-296-1080 Start Date*: 2016-04-04
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastr...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10066354 Adenocarcinoma of the gastroesophageal junction LLT
    19.1 100000004864 10071114 Metastatic gastric adenocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PL (Prematurely Ended) DE (Completed) HU (Completed) ES (Prematurely Ended) RO (Completed) CZ (Completed) FR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020002-15 Sponsor Protocol Number: A3921061 Start Date*: 2010-11-15
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
    Medical condition: Moderate To Severe Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Completed) GB (Completed) NL (Completed) FI (Prematurely Ended) ES (Completed) DK (Prematurely Ended) SE (Prematurely Ended) BG (Prematurely Ended) SK (Prematurely Ended) HU (Prematurely Ended) AT (Completed) GR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004949-32 Sponsor Protocol Number: P1-GM-101 Start Date*: 2021-03-30
    Sponsor Name:Lysogene
    Full Title: An open-label adaptive-design study of intracisternal administration of adeno-associated viral vector serotype rh.10 carrying the human β-galactosidase cDNA for the treatment of GM1 gangliosidosis
    Medical condition: GM1 gangliosidosis
    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: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004273-27 Sponsor Protocol Number: CUETO1801 Start Date*: 2019-04-08
    Sponsor Name:PRESURGY, S.
    Full Title: Multicenter clinical trial with medical device associated with a drug in an authorised therapeutic use for the treatment of CVNMI evaluating the efficacy and tolerability of the adyuvant treatment ...
    Medical condition: bladder cancer non muscle invasive in high risk patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10029759 Normal delivery LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-018315-15 Sponsor Protocol Number: D589GC00001 Start Date*: 2010-06-09
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 μg bid with placebo, a 6-week efficacy and safety study in children aged 6 ...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003553 Asthma LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SK (Prematurely Ended) LV (Completed) HU (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2020-001056-17 Sponsor Protocol Number: 3606 Start Date*: 2020-08-14
    Sponsor Name:Kings's College London [...]
    1. Kings's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
    Medical condition: Clinically significant agitation in Alzheimer's Diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-002300-12 Sponsor Protocol Number: EPOS_ZKSJ0134 Start Date*: 2021-12-20
    Sponsor Name:Friedrich Schiller University
    Full Title: Epirubicin for the Treatment of Sepsis & Septic Shock
    Medical condition: Patients with sepsis or septic shock, currently hospitalized at the Intensive Care Unit (ICU) or Intermediate Care (IMC) regardless where the sepsis was first diagnosed.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000295-42 Sponsor Protocol Number: GFT505-212-7 Start Date*: 2012-09-11
    Sponsor Name:GENFIT
    Full Title: A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).
    Medical condition: Patients with Non-Alcoholic Steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) GB (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-002627-32 Sponsor Protocol Number: 2007-002627-32 Start Date*: 2009-02-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5mg fingolimod administered orally once daily versus placebo in patients wit...
    Medical condition: Primary progressive multiple sclerosis.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) FI (Completed) SE (Completed) ES (Completed) FR (Completed) IT (Completed) DE (Completed) NL (Completed) BE (Completed) HU (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002775-17 Sponsor Protocol Number: 1010 Start Date*: 2013-10-29
    Sponsor Name:Andromeda Biotech Ltd
    Full Title: OPEN-LABEL STUDY TO EVALUATE LONG TERM SAFETY AND TREATMENT EFFECT OF DIAPEP277® IN SUBJECTS WHO HAVE COMPLETED STUDY 1001
    Medical condition: Type I diabetes
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004861 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) AT (Prematurely Ended) LT (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-007555-14 Sponsor Protocol Number: C10953/2032/DP/US Start Date*: 2008-08-15
    Sponsor Name:Cephalon, Inc.
    Full Title: An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major ...
    Medical condition: Major Depression Associated With Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057840 Major depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-005326-36 Sponsor Protocol Number: Kamada-AAT(inhaled)-007 Start Date*: 2009-11-02
    Sponsor Name:Kamada Limited
    Full Title: A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin...
    Medical condition: Alpha-1 Antitrypsin deficiency in patients with emphysema.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10001806 Alpha-1 anti-trypsin deficiency PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) SE (Completed) DK (Completed) DE (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003519-40 Sponsor Protocol Number: 03-CL-1202 Start Date*: 2016-02-18
    Sponsor Name:Windtree Therapeutics, Inc
    Full Title: A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE WITH RESPIRATOR...
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) IE (Completed) NL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2018-000106-32 Sponsor Protocol Number: 03-CL-1702 Start Date*: 2019-06-26
    Sponsor Name:Windtree Therapeutics, Inc.
    Full Title: A Multinational, Multicenter, Masked, Randomized, Parallel Group, Controlled Study to Assess the Safety and Efficacy of Lucinactant for Inhalation versus nCPAP alone in Preterm Neonates 26 to 32 We...
    Medical condition: Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002625-29 Sponsor Protocol Number: GWSP19066 Start Date*: 2020-01-14
    Sponsor Name:GW Pharma Limited
    Full Title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis
    Medical condition: Symptomatic treatment of spasticity in patients with multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10028335 Muscle spasticity PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) GB (GB - no longer in EU/EEA) CZ (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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