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Clinical trials for Drug tolerability

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    6,549 result(s) found for: Drug tolerability. Displaying page 1 of 328.
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    EudraCT Number: 2009-017828-54 Sponsor Protocol Number: 1131/09 Start Date*: 2011-03-28
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to -lactams.
    Medical condition: allergy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013661 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000455-16 Sponsor Protocol Number: CYT/Heparin_01/11 Start Date*: 2011-05-05
    Sponsor Name:CYATHUS EXQUIRERE PharmaforschungsGmbH
    Full Title: Efficacy and local tolerability of topically applied heparin (Heparin 2,400 IU/ml Cutaneous Spray) on the suitability of newly constructed primary arteriovenous Fistulas in haemodialysed patients
    Medical condition: This placebo-controlled, randomized and double-blinded pilot study aims to confirm the previous study performed by Stuard et al. (2010) by proving clinically efficacy and local tolerability of topi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001070-29 Sponsor Protocol Number: CRF005 Start Date*: 2023-05-26
    Sponsor Name:Chelsea and Westminster NHS Foundation Trust
    Full Title: Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)
    Medical condition: Human Immunodeficiency Virus (HIV) infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10020441 Human immunodeficiency virus infection, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003901-93 Sponsor Protocol Number: RC2019.1.6_GIAQUINTO Start Date*: 2020-05-27
    Sponsor Name:IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    Full Title: Monocentric, indipendent, phase II clinical trial, randomized in open to three different lZ delivery sequences in pediatric patients aged 1 and 12, in intensive care and mechanically ventilated.
    Medical condition: Critical patients subjected to mechanical ventilation and hospitalized in PICU
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003319-23 Sponsor Protocol Number: SLF_SCMO_0113 Start Date*: 2013-11-07
    Sponsor Name:Fondazione IRCCS Istituto Nazionale dei Tumori
    Full Title: SUBLINGUAL FENTANYL VERSUS SUBCUTANEOUS MORPHINE FOR THE MANAGEMENT OF SEVERE CANCER PAIN EPISODES IN PATIENTS ON OPIOID TREATMENT: A DOUBLE-BLIND RANDOMIZED NON–INFERIORITY TRIAL.
    Medical condition: pain due to cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000630-17 Sponsor Protocol Number: MER-XMT-1536-1 Start Date*: 2021-09-21
    Sponsor Name:Mersana Therapeutics, Inc.
    Full Title: A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
    Medical condition: High grade serous ovarian cancer or non-small cell lung cancer (NSCLC), adenocarcinoma subtype
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NO (Completed) LT (Completed) CZ (Completed) HU (Completed) BG (Completed) FI (Completed) PL (Completed) DK (Completed) IT (Completed) AT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2005-001967-70 Sponsor Protocol Number: AC-052-367 Start Date*: 2005-10-13
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertensi...
    Medical condition: Idiopathic or familial pulmonary arterial hypertension
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    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: 2014-004603-78 Sponsor Protocol Number: MK-0869-097-02 Start Date*: 2015-02-13
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Preventio...
    Medical condition: chemotherapy induced nausea and vomiting
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001177-93 Sponsor Protocol Number: SYL1001_II Start Date*: 2012-10-18
    Sponsor Name:Sylentis
    Full Title: PILOT TRIAL FOR ASSESSMENT TOLERABILITY AND EFFECT OF SYL1001 IN PATIENS WITH OCULAR PAIN
    Medical condition: PATIENTS WITH DIAGNOSIS OF OCULAR PAIN MILD TO MODERATE AND DRY EYE MILD TO MODERATE
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-011013-24 Sponsor Protocol Number: AC-063A302 Start Date*: 2009-06-03
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symp...
    Medical condition: Indication: Symptomatic Pulmonary Arterial Hypertension
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000579-19 Sponsor Protocol Number: MAGNET Start Date*: 2021-06-25
    Sponsor Name:Stichting TRICALS Foundation
    Full Title: A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS)
    Medical condition: Amyotrophic Lateral Sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004827-29 Sponsor Protocol Number: VX14-661-110 Start Date*: 2015-09-01
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, ...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed) IE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) SE (Completed) AT (Completed) FR (Completed) DK (Completed) NL (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-004431-23 Sponsor Protocol Number: WN41874 Start Date*: 2020-06-03
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL, MULTI-CENTER, ROLL-OVER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF LONG-TERM ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH ALZHEIMER’S DISEASE
    Medical condition: Alzheimer’s disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Ongoing) PL (Prematurely Ended) GB (GB - no longer in EU/EEA) DK (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006968-11 Sponsor Protocol Number: AP214-CS005 Start Date*: 2009-04-21
    Sponsor Name:Action Pharma A/S
    Full Title: Pharmacokinectics of AP214 Acetate in patients undergoing cardiac surgery. A randomized, double-blind, placebo-controlled sequential ascending dose trial investigating pharmacokinetics, as well as...
    Medical condition: Action Pharma A/S is developing AP214 Acetate for the prevention of postsurgical kidney injury after thoracic aortic aneurysm repair surgery. In phase 2: Patients undergoing cardiac surgery, defin...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056675 Postoperative renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002481-78 Sponsor Protocol Number: EBI-EA230-LPS-2014 Start Date*: 2014-10-07
    Sponsor Name:Exponential Biotherapies Inc
    Full Title: Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune resp...
    Medical condition: Systemic inflammatory respons (SIRS) and associated acute kidney injury (AKI)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-014765-74 Sponsor Protocol Number: Fluval P-H-08 Start Date*: 2009-08-13
    Sponsor Name:Omninvest Ltd.
    Full Title: Tolerability and Safety Study of Fluval P Monovalent Influenza Vaccine in Children
    Medical condition: Immunization of children against infection caused by pandemic influenza (H1N1)09 virus.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059429 Influenza immunisation LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2013-003457-25 Sponsor Protocol Number: AC-055E202 Start Date*: 2014-06-13
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic...
    Medical condition: Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10068739 Chronic thromboembolic pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) DE (Completed) AT (Completed) NL (Completed) LT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003536-12 Sponsor Protocol Number: CIGE025B1301E1 Start Date*: 2016-02-16
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite...
    Medical condition: Allergic Asthma
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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