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Clinical trials for 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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    14,030 result(s) found for: Tolerability. Displaying page 2 of 702.
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    EudraCT Number: 2013-001788-21 Sponsor Protocol Number: RO-2455-302-RD Start Date*: 2014-04-11
    Sponsor Name:TAKEDA DEVELOPMENT CENTRE EUROPE LTD
    Full Title: A multicenter, randomized, double-blind phase 3 study to evaluate tolerability and pharmacokinetics of 500μg roflumilast once daily with an up-titration regimen in COPD, including an open-label do...
    Medical condition: chronic obstructive pulmonary disease (COPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed) DE (Completed) HU (Completed) RO (Completed) GR (Completed) BG (Completed)
    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: 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: 2006-000991-34 Sponsor Protocol Number: DMP 81.1.05 Start Date*: 2006-04-21
    Sponsor Name:Dr. Gerhard Mann, Chem-pharm. Fabrik GmbH
    Full Title: A randomized, double-blind, monocentric phase IV clinical study on the ocular tolerability of a topical ophthalmic product containing Retinolpalmitat 1000 I.U. in comparison to a reference product ...
    Medical condition: Patients suffering from keratoconjunctivitis sicca (dry eye) and break-up-time (BUT) values < 10 sec
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-003592-48 Sponsor Protocol Number: BUP/006/C Start Date*: 2008-11-25
    Sponsor Name:Novosis AG
    Full Title: A double-blind, multi-centre, reference-controlled, randomised Phase III study to compare the analgesic efficacy and tolerability of a buprenorphine transdermal system in two different application ...
    Medical condition: Patients with chronic, severe cancer pain requiring strong opioids and inadequately controlled with other analgesics.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005187-25 Sponsor Protocol Number: BUC-SI-11-001 Start Date*: 2012-05-31
    Sponsor Name:SOCIETA' LABORATORIO FARMACEUTICO S.I.T. SRL
    Full Title: Efficacy and tolerability clinical trial of an immunostimulant made from inactivated bacteria (BUCCALIN) in the prophylaxis of infection of the airways (rhinotracheobronchitis, colds). Double-blind...
    Medical condition: Episodes classified by upper respiratory infections (otitis, tonsillitis, sinusitis, pharyngotonsillitis, nasopharyngitis) and lower respiratory tract (bronchitis, pneumonia).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10060693 Respiratory tract infection bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001851-29 Sponsor Protocol Number: BAY2253651/19038 Start Date*: 2018-07-25
    Sponsor Name:Bayer AG
    Full Title: Randomized, multi-center, double-blind, placebo-controlled, group-comparison study to investigate safety, tolerability and pharmacodynamics of BAY2253651 after administration of a single nasal dose...
    Medical condition: Obstructive sleep Apnea
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10055577 Obstructive sleep apnea syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-004606-24 Sponsor Protocol Number: 04.168-11 Start Date*: 2005-01-24
    Sponsor Name:Fujisawa GmbH
    Full Title: A randomized, open-label, monocentric clinical phase I/IV study in healthy human volunteers to evaluate the skin tolerability and cosmetic acceptance of three marketed anti-acne drugs (Differin® Cr...
    Medical condition:
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (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: 2007-006778-26 Sponsor Protocol Number: 07ct/am04perm Start Date*: 2008-07-17
    Sponsor Name:gepepharm GmbH
    Full Title: Investigation of the local tolerability of pedimitex creme 5% - a permethrine containing creme - in 100 patients with scabies infection of both gender
    Medical condition: The product is intended to be used by patients suffering from scabies infestation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039512 Scabies infestation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001691-21 Sponsor Protocol Number: GR-OG-279239-02 Start Date*: 2016-05-17
    Sponsor Name:Genera Research Ltd
    Full Title: SAFETY, TOLERABILITY, rhBMP6 PHARMACOKINETICS AND BONE HEALING EFFECT OF A SINGLE DOSE OF OSTEOGROW (rhBMP6 IN AUTOLOGOUS WHOLE BLOOD COAGULUM DERIVED [WBCD] CARRIER) IN ADULT PATIENTS TREATED BY H...
    Medical condition: Osteoarthritis of the medial knee joint compartment and/or symptomatic varus deformity.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10031300 Osteotomy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000548-23 Sponsor Protocol Number: UKE-SARS-COV-2-ST Start Date*: 2021-07-07
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: A multi-center, phase Ib trial to assess the safety, tolerability and immunogenicity of the candidate vaccine MVA-SARS-2-ST in adults
    Medical condition: This study is designed to evaluate the safety, tolerability and reactogenicity of intramuscular dose administrations of: -3 dose levels of the MVA-SARS-2-ST vaccine in healthy SARS-CoV-2 seronegati...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003609-14 Sponsor Protocol Number: ZLB07_001CR Start Date*: 2015-01-05
    Sponsor Name:CSL Behring
    Full Title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
    Medical condition: Primary Immune Deficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003749-14 Sponsor Protocol Number: BLI800-501 Start Date*: 2020-01-02
    Sponsor Name:Braintree Laboratories
    Full Title: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
    Medical condition: Colonoscopy
    Disease: Version SOC Term Classification Code Term Level
    21.0 10022891 - Investigations 10010007 Colonoscopy PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-003839-31 Sponsor Protocol Number: ELN100226-CD354 Start Date*: 2005-02-05
    Sponsor Name:Elan Pharma Ltd.
    Full Title: A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Stud...
    Medical condition: Crohn's Disease (CD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000686-35 Sponsor Protocol Number: CLIC477D2302E01 Start Date*: 2005-04-29
    Sponsor Name:Novartis Pharma AG
    Full Title: A 52-week open-label extension study to evaluate the safety and tolerability of licarbazepine 750-2000 mg/d in the treatment of manic episodes of bipolar I disorder
    Medical condition: Bipolar I disorder, manic and mixed episodes
    Disease:
    Population Age: Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004437-16 Sponsor Protocol Number: tobra-02 Start Date*: 2013-05-15
    Sponsor Name:University Medical Center Groningen
    Full Title: Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis
    Medical condition: Bronchiectasis Lung infections
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000404-10 Sponsor Protocol Number: HCSC-BIMATOPROSTUD-13 Start Date*: 2015-06-10
    Sponsor Name:Hospital Clinico San Carlos
    Full Title: Effectiveness, tolerability and impact in the ocular surface of Bimatoprost and Tafluprost pods in patients with glaucoma and ocular hypertension
    Medical condition: Glaucoma andr ocular hypertension
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001988-23 Sponsor Protocol Number: AEZS-130-P01 Start Date*: 2018-11-07
    Sponsor Name:Aeterna Zentaris GmbH
    Full Title: Open label, group comparison, dose escalation trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of macimorelin acetate after single oral dosing of 0.25 mg/kg, 0.5 mg/...
    Medical condition: Diagnosis of Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10073227 Growth hormone stimulation test LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007519-34 Sponsor Protocol Number: FAST VERSION Start Date*: 2009-04-17
    Sponsor Name:University of Leuven Hospitals, Division of Gastroenterology
    Full Title: Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST
    Medical condition: This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerab...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
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    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.
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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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