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Clinical trials for Bilastine

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
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    The EU Clinical Trials Register currently displays   44334   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 ).  
     
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    21 result(s) found for: Bilastine. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-000181-21 Sponsor Protocol Number: BUCSU Start Date*: 2014-07-02
    Sponsor Name:Charite - Universitätsmedizin Berlin
    Full Title: Disease activity controlled dose escalating study to assess the efficacy, and safety of treatment with bilastine 20 mg, 40 mg and 80 mg in chronic spontaneous urticaria.
    Medical condition: Chronic Spontaneous Urticaria
    Disease: Version SOC Term Classification Code Term Level
    17.0 10040785 - Skin and subcutaneous tissue disorders 10072757 Chronic spontaneous urticaria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-019344-39 Sponsor Protocol Number: BUCUM1 Start Date*: 2010-08-09
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: Double-blind, triple cross-over, placebo-controlled study to assess the efficacy, mechanisms, and safety of treatment with bilastine 20 mg, 40 mg and 80 mg in cold contact urticaria (CCU) Compound:...
    Medical condition: Cold contact urticaria
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003299-22 Sponsor Protocol Number: BILA-3514/SCA Start Date*: 2014-11-18
    Sponsor Name:TNO.Netherlands Organization for Applied Scientific Research
    Full Title: Effects of Single Dose of Bilastine 20mg on Flying Ability in Healthy Volunteers Under Conditions of Simulated Cabin Pressure
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003002-91 Sponsor Protocol Number: MEIN/13/Bil-Ang/001 Start Date*: 2013-11-04
    Sponsor Name:Menarini International Operation Luxembourg SA
    Full Title: Pilot study on efficacy and safety of bilastine in preventing angioedema attacks in patients with recurrent angioedema of unkown etiology (idiopatic angioedema, rIAE)
    Medical condition: recurrent idiopathic angioedema
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004806-40 Sponsor Protocol Number: MEIN/15/Bil-ARC/001 Start Date*: 2016-03-29
    Sponsor Name:Menarini International Operations Luxembourg S.A.
    Full Title: Bilastine and Montelukast in patients with seasonal allergic rhinoconjunctivitis and asthma: Efficacy of concomitant administration - the SKY study; Acronym: SKY
    Medical condition: Seasonal allergic rhinoconjunctivitis and asthma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Completed) PL (Completed) LV (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003506-27 Sponsor Protocol Number: BILA-3312/PED Start Date*: 2013-01-25
    Sponsor Name:FAES FARMA, S.A.
    Full Title: A multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with e...
    Medical condition: Allergic Rhinoconjunctivitis and Chronic Urticaria
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) PT (Completed) PL (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005824-13 Sponsor Protocol Number: MEIN/12/Bil-Ang/001 Start Date*: 2013-03-23
    Sponsor Name:Menarini International Operation Luxembourg SA
    Full Title: Pilot study on efficacy of bilastine in preventing angioedema symptoms in patients with angioedema of unknown etiology (idiopathic angioedema, IAE)
    Medical condition: idiopathic angioedema
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004214-96 Sponsor Protocol Number: MEIN/15/Bil-PSR/002 Start Date*: 2017-02-02
    Sponsor Name:MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
    Full Title: Bilastine and inflammation: an explorative study in subjects affected by Parietaria J.-induced Rhinoconjunctivitis – The Bi-FLO study
    Medical condition: Rhinoconjunctivitis induced by Parietaria J.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001728 Allergic rhinoconjunctivitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003940-21 Sponsor Protocol Number: BILA-3918/PED Start Date*: 2019-01-11
    Sponsor Name:FAES FARMA, S.A.
    Full Title: A pilot, multicentre, single-blind, randomized, placebo-controlled, parallel-group clinical trial, to assess the safety of Bilastine treatment regarding psychomotor performance using a virtual real...
    Medical condition: Allergic rhinoconjunctivitis (both seasonal allergic rhinitis -SAR- and perennial allergic rhinitis -PAR-) and/or urticaria.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-002248-95 Sponsor Protocol Number: BOFT-0418-SAFE Start Date*: 2018-09-26
    Sponsor Name:FAES FARMA S.A.
    Full Title: Multi-centre, randomised, double blind, placebo-controlled, parallel, phase III study to assess the safety, tolerability and efficacy of bilastine ophthalmic solution 0.6% in adults
    Medical condition: Allergic Conjunctivitis (AC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001709 Allergic conjunctivitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) HU (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-000913-19 Sponsor Protocol Number: BILA-3818/PD Start Date*: 2018-05-11
    Sponsor Name:FAES FARMA, S.A.
    Full Title: Phase IV, single centre, randomised, open-label, two-period, two-way crossover clinical trial to assess the efficacy of Bilastine 20mg in the suppression of wheal and flare induced by intradermal h...
    Medical condition: ALLERGIC RHINOCONJUNTIVIS AND CHRONIC URTICARIA
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-001245-33 Sponsor Protocol Number: BILA 2006/UCI Start Date*: 2006-07-31
    Sponsor Name:FAES FARMA S.A.
    Full Title: “Estudio en fase III, doble ciego, randomizado, controlado con placebo, comparativo de la eficacia y seguridad de bilastina 20 mg una vez al día y levocetirizina 5 mg para el tratamiento de la ...
    Medical condition: Chronic Idiopathic Urticaria
    Disease: Version SOC Term Classification Code Term Level
    8.1 10021247 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003004-19 Sponsor Protocol Number: BILA-2306/ACC Start Date*: 2006-09-26
    Sponsor Name:FAES Farma S.A.
    Full Title: A randomised, double-blind, four way cross-over, placebo controlled trial to evaluate the clinical efficacy, onset of action and drug activity at 22-26 hours following the drug intake of Bilastne 2...
    Medical condition: Seasonal Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039083 Rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2004-004586-14 Sponsor Protocol Number: BILA 1704/RAE Start Date*: 2005-05-13
    Sponsor Name:FAES FARMA S.A.
    Full Title: Double-blind, randomised, placebo-controlled, phase III study comparing the efficacy and safety of bilastine 20 mg once daily and cetirizine 10 mg for the treatment of allergic allergic rhinitis
    Medical condition: Seasonal Allergic Rhinitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) DE (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003011-26 Sponsor Protocol Number: BILA-4021/PED Start Date*: 2021-10-26
    Sponsor Name:FAES FARMA S.A.
    Full Title: A multicentre, open-label clinical trial to assess plasma levels and safety of bilastine in children from 2 to 5 years of age with seasonal and/or perennial allergic rhinoconjunctivitis or urticaria
    Medical condition: Allergic rhinoconjunctivitis. Urticaria.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001728 Allergic rhinoconjunctivitis LLT
    20.0 10040785 - Skin and subcutaneous tissue disorders 10046735 Urticaria PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-012013-22 Sponsor Protocol Number: BILA-3009/PED Start Date*: 2009-12-09
    Sponsor Name:FAES FARMA S.A.
    Full Title: A Multicentre, International, Adaptive, Open-label, Repeated Administration Pharmacokinetic Study of Bilastine in Children from 2 to <12 Years of age with Allergic Rhinoconjunctivitis or Chronic Ur...
    Medical condition: Allergic Rhinoconjunctivitis and chronic urticaria
    Disease: Version SOC Term Classification Code Term Level
    12.0 10001728 Allergic rhinoconjunctivitis LLT
    12.0 10009159 Chronic urticaria LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004830-32 Sponsor Protocol Number: ICPCT-2011-UA-FF Start Date*: 2012-01-27
    Sponsor Name:FAES FARMA, S.A.
    Full Title: Effects of bilastine on nasal volume after allergen-induced rhinitis in patients with allergic rhinitis
    Medical condition: Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10039085 Rhinitis allergic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002098-86 Sponsor Protocol Number: BOFT-0520/PED Start Date*: Information not available in EudraCT
    Sponsor Name:FAES FARMA, S.A.
    Full Title: Multi-centre, randomised, double blind, placebo-controlled, parallel, phase III study to assess the safety, tolerability and efficacy of Bilastine ophthalmic solution 0.6% in children
    Medical condition: Allergic conjunctivitis (AC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001709 Allergic conjunctivitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-001313-26 Sponsor Protocol Number: MEIN/14/Bil-ARU/001 Start Date*: 2015-07-15
    Sponsor Name:MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
    Full Title: Effects of Bilastine on F1 Simulator driving performance in patients affected by allergic rhinitis and/or urticaria
    Medical condition: allergic rhinitis (seasonal or perennial) and/or urticaria
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004870 10039095 Rhinitis seasonal LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10039094 Rhinitis perennial PT
    19.0 100000004858 10009159 Chronic urticaria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001505-17 Sponsor Protocol Number: BILA-3716/PRU Start Date*: 2016-07-29
    Sponsor Name:FAES FARMA, S.A.
    Full Title: An exploratory study to evaluate the efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases.
    Medical condition: Chronic spontaneous urticaria and the following skin disorders: 1 - Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitisation dermat...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10040785 - Skin and subcutaneous tissue disorders 10012435 Dermatitis and eczema HLT
    19.0 10040785 - Skin and subcutaneous tissue disorders 10037083 Prurigo PT
    19.0 10040785 - Skin and subcutaneous tissue disorders 10052568 Urticaria chronic PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (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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