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Clinical trials for Center for Drug Evaluation and Research

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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    167 result(s) found for: Center for Drug Evaluation and Research. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2011-005336-25 Sponsor Protocol Number: DMKS-2011 Start Date*: 2012-03-23
    Sponsor Name:Chemische Fabrik Kreussler & Co. GmbH
    Full Title: A randomiszed, mono-center, placebo-controlled, double-blind, comparative study to evaluate the efficacy and safety of Dynexan® Mundgel in minors with acute painful sites of the mouth.
    Medical condition: Painful sites in the mouth
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003770-85 Sponsor Protocol Number: DKFZ-2019-007 Start Date*: 2020-08-20
    Sponsor Name:German Cancer Research Center (DKFZ)
    Full Title: Effect of low-dose acetylsalicylic acid on early detection of advanced colorectal neoplasms
    Medical condition: Screening for advanced colorectal neoplasms. Male individuals aged 40 to 79 years scheduled for screening colonscopy and no use of acetylsalicylic acid (or other drugs with an effect on the blood ...
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-003461-35 Sponsor Protocol Number: 20210096 Start Date*: 2022-02-22
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab plus Chemotherapy versus Placebo plus Chemotherapy in Subjects with Previously Untreated Advanced Gastric...
    Medical condition: Untreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b Overexpression
    Disease: Version SOC Term Classification Code Term Level
    23.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10084227 Gastroesophageal junction cancer LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017758 Gastric cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) FR (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) HU (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) SE (Trial now transitioned) BG (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) NO (Trial now transitioned) IE (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-005630-21 Sponsor Protocol Number: RG_06-180 Start Date*: 2009-04-09
    Sponsor Name:University of Birmingham [...]
    1. University of Birmingham
    2. Birmingham Heartlands Hospital
    Full Title: The effect of Pregabalin on Pain progressing in Painful Diabetic Neuropathy
    Medical condition: Diabtes and its complications, painful neuropathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003300-31 Sponsor Protocol Number: 20159460(c) Start Date*: 2017-06-13
    Sponsor Name:Hellenic Society for the Study of Bone Metabolism
    Full Title: Evaluation of the efficacy of Denosumab in adult patients with Langerhans Cell Histiocytosis (LCH) : a multiple-site, single arm, open label Clinical Trial.
    Medical condition: Langerhans Cell Histiocytosis (LCH) is a rare disease of unknown etiology with variable clinical course exhibiting both neoplastic and inflammatory features. It is characterized by the accumulatio...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10069698 Langerhans' cell histiocytosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-003287-25 Sponsor Protocol Number: 2018-002863-24,2022-003287-25 Start Date*: 2023-04-10
    Sponsor Name:Erasmus University Medical Center - Sophia Childrens Hospital
    Full Title: Intralesional steroid injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled trial
    Medical condition: Recurrent anastomotic strictures in the esophagus following surgical repair with primary anastomosis of esophageal atresia in neonates.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-002334-39 Sponsor Protocol Number: RGH-MD-56 Start Date*: 2012-04-09
    Sponsor Name:Forest Research Institute, Inc
    Full Title: A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
    Medical condition: Bipolar I Disorder Major Depressive Episode
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-002766-31 Sponsor Protocol Number: 1200.277 Start Date*: 2018-11-23
    Sponsor Name:UCL
    Full Title: A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first line or later line treatment in advanced chordoma
    Medical condition: Chordoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008747 Chordoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001636-22 Sponsor Protocol Number: TROPICALACS Start Date*: 2013-08-26
    Sponsor Name:Hospital of the University of Munich, Grosshadern
    Full Title: A prospective, randomized, parallel-group, open label, non-inferiority, multicenter trial of a 12 month vs. a short-term platelet function testing guided prasugrel therapy in acute coronary syndrom...
    Medical condition: Troponin positive acute coronary syndrome after successful percutaneous coronary intervention with an indication for a standard treatment of 12 month with prasugrel
    Disease: Version SOC Term Classification Code Term Level
    19.1 10007541 - Cardiac disorders 10051592 Acute coronary syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) AT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000068-30 Sponsor Protocol Number: ECT-001 Start Date*: 2021-12-15
    Sponsor Name:Ectin Research AB
    Full Title: An open-label, multi-center, phase I/II study of MFA-370 in patients with metastatic urothelial cancer
    Medical condition: Metastatic urothelial cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) LT (Prematurely Ended) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-005687-27 Sponsor Protocol Number: TAK-242_301 Start Date*: 2008-08-06
    Sponsor Name:Takeda Global Research & Development Centre (Europe), Ltd. [...]
    1. Takeda Global Research & Development Centre (Europe), Ltd.
    2. Takeda Global Research & Development Centre (Europe), Ltd.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis Induced Cardiovascular and Respiratory Failure
    Medical condition: Septic shock and respiratory failure.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040070 Septic shock PT
    9.1 10038695 Respiratory failure PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) FI (Completed) CZ (Prematurely Ended) HU (Prematurely Ended) FR (Completed) AT (Prematurely Ended) NL (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-003950-15 Sponsor Protocol Number: rhLAMAN-10 Start Date*: 2015-01-22
    Sponsor Name:Zymenex A/S
    Full Title: A single center, open label clinical trial investigating the long-term efficacy of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) treatment in subjects with alpha-Mannosidosis who previo...
    Medical condition: alpha-Mannosidosis
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10032658 Other specified disorders of carbohydrate transport and metabolism LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-004452-42 Sponsor Protocol Number: STABIL-NOR Start Date*: 2022-12-14
    Sponsor Name:Helse Bergen HF
    Full Title: An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR –...
    Medical condition: Drug induced weight gain from anti-psychotic drug treatment in patients with schizophrenia. Treatment with semaglutide, a glucagon-like peptide receptor agonist used to treat diabetes and approv...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10029883 Obesity PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021037-32 Sponsor Protocol Number: I4T-MC-JVBB(e) Start Date*: 2011-01-12
    Sponsor Name:Eli Lilly and Company Limited, Indianapolis
    Full Title: A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progress...
    Medical condition: Metastatic Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10010036 Colorectal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) FR (Completed) AT (Completed) NL (Completed) ES (Completed) PT (Completed) DE (Completed) IT (Completed) SE (Completed) BE (Completed) DK (Completed) GR (Completed) HU (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2018-001435-52 Sponsor Protocol Number: APL2-304 Start Date*: 2018-12-10
    Sponsor Name:Apellis Pharmaceuticals Inc.
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy with Sham Injections in Patients with Geographic A...
    Medical condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10063947 Geographic atrophy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016080-11 Sponsor Protocol Number: DIPGstudyVUmc01 Start Date*: 2011-02-25
    Sponsor Name:VU University Medical Center
    Full Title: A COMPREHENSIVE AND TARGETED THERAPY APPROACH IN PEDIATRIC MALIGNANT PONTINE GLIOMAS
    Medical condition: Pediatric malignant pontine gliomas
    Disease: Version SOC Term Classification Code Term Level
    12.1 10006143 Brain stem glioma LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-003278-93 Sponsor Protocol Number: KF5503/34-R331333-PAI-3004 Start Date*: 2007-01-31
    Sponsor Name:Johnson & Johnson Pharamceutical Research & Development, L.L.C.
    Full Title: Randomized, Double-Blind, Active-Control, Parallel Group, 90-Day Safety Study of CG5503 Immediate Release or Oxycodone Immediate Release in Subjects With Chronic Pain from Low Back Pain or Osteoart...
    Medical condition: moderate to severe pain
    Disease: Version SOC Term Classification Code Term Level
    8.1 10033371 Pain LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-011498-34 Sponsor Protocol Number: TAS 2009 Start Date*: 2009-10-22
    Sponsor Name:Ergomed Clinical Research Limited
    Full Title: An Open-Label, Multi-Center Phase I/II Dose Escalation Study to Investigate the Safety and Tolerability of Multiple Doses of Oral Tasidotin HCL in Patients with Advanced Solid Tumors (part A), and ...
    Medical condition: Solid tumours and metastatic melanoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065143 Malignant solid tumour LLT
    9.1 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002526-67 Sponsor Protocol Number: 2012-482 Start Date*: 2012-07-02
    Sponsor Name:Sten Madsbad
    Full Title: Treatment with Liraglutide in type 1 diabetic patients. Effects on glycemic control and counterregulation and cognitive performance during hypoglycaemia.
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10045228 Type I diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000784-26 Sponsor Protocol Number: IM101-023 Start Date*: 2005-11-25
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate...
    Medical condition: Rheumatoid Arthritis, Nos
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) ES (Completed) DE (Completed) CZ (Completed) BE (Completed) AT (Prematurely Ended) IT (Completed)
    Trial results: Removed from public view
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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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