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Clinical trials for Rupatadine

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    14 result(s) found for: Rupatadine. Displaying page 1 of 1.
    EudraCT Number: 2013-003542-17 Sponsor Protocol Number: CU-LATER Start Date*: 2014-06-11
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: A multi-center, randomized, double blind, dose escalating phase III study on the efficacy, safety and long term outcome of continuous vs. on demand treatment of chronic spontaneous urticaria with r...
    Medical condition: Chronic Spontaneous Urticaria
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-004094-93 Sponsor Protocol Number: PAFCUTIII Start Date*: 2012-04-19
    Sponsor Name:Allergie-Centrum Charité
    Full Title: Double-blind, three-way cross-over, placebo controlled study to assess the efficacy, safety and mechanisms of treatment with rupatadine 20 and 40mg in cold contact urticaria (CCU)
    Medical condition: Cold contact urticaria
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10009869 Cold urticaria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-000771-34 Sponsor Protocol Number: IC010RUP/3/04 Start Date*: 2004-10-28
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: A 6-week multicentre, double-blind, randomised, placebo-controlled, parallel-group study to assess the efficacy and safety of rupatadine 10 and 20 mg in the treatment of Chronic Idiopathic Urticar...
    Medical condition: Chronic Idiopathic Urticaria
    Disease: Version SOC Term Classification Code Term Level
    7 10021247 0
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004422-50 Sponsor Protocol Number: DM03RUP/IV/05 Start Date*: 2006-01-11
    Sponsor Name:J.Uriach y Compania S.A.,
    Full Title: A placebo-controlled, double-blind, cross-over study with rupatadine 10 mg in 30 mosquito-bite allergic adult subjects Rupatadiini-antihistamiini hyttyspistoallergiassa
    Medical condition: mosquito-bite allergic adults
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-021361-69 Sponsor Protocol Number: DC01/RUP/2/09 Start Date*: 2010-09-13
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: A multicenter, open-label study to assess pharmacokinetics, efficacy, tolerability and safety of Rupatadine in paediatrics patients (2-5 years old) with allergic rhinitis.
    Medical condition: Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10001723 Allergic rhinitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005135-73 Sponsor Protocol Number: DC05DUO/2/20 Start Date*: 2021-02-16
    Sponsor Name:Biohorm S.L
    Full Title: A Randomised, Double-blind, Two-arm, Parallel Groups, Multicentre Study to evaluate the efficacy and safety of a Fixed Dose Combination of Rupatadine and Montelukast vs. Rupatadine in adult patient...
    Medical condition: Seasonal allergic rhinitis with and without mild to moderate bronchial asthma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10001723 Allergic rhinitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004900-37 Sponsor Protocol Number: DC05/RUP/I/13 Start Date*: 2012-11-20
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel group study to assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral Rupatadine in Healthy Japanese Subjec...
    Medical condition: This is a Phase I study in helathy subjects. No condition is being treated. The IMP is approved for symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 yea...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003108-20 Sponsor Protocol Number: DM04RUP/IV/05 Start Date*: 2006-11-29
    Sponsor Name:URIACH J. URIACH Y COMPANIA S.A.
    Full Title: A DOUBLE BLIND, RANDOMISED, PARALLEL, PLACEBO-CONTROLLED, PILOT STUDY TO EVALUATE THE ANTI-INFLAMMATORY EFFECTS AND THE EFFICACY OF RUPATADINE 10 MG ON THE SYMPTOMS OF PERSISTENT ALLERGIC RHINITIS
    Medical condition: PAR
    Disease: Version SOC Term Classification Code Term Level
    6.1 10039085 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-001130-16 Sponsor Protocol Number: IC011RUP/4/04 Start Date*: Information not available in EudraCT
    Sponsor Name:J. URIACH & COMPAÑIA
    Full Title: 12 months long term safety and tolerability of Rupatadine 10 mg in the treatment of moderate-severe persistent allergic rhinitis.
    Medical condition: Perennial allergic rhinitis is a autoinmuno disease and its pathopshysiology is based on released of several mediators, such as histamine. The symptoms include: itchy eyes and palate, runny nose, s...
    Disease: Version SOC Term Classification Code Term Level
    6 10039094 pt
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005786-35 Sponsor Protocol Number: DC02RUP/IV/02 Start Date*: Information not available in EudraCT
    Sponsor Name:Uriach Pharma
    Full Title: Proof-of-concept, cross over, double blind, placebo-controlled study to assess if Rupatadine 20 mg can improve critical stimulation time thresholds (CSTTs) in patients with acquired cold urticaria
    Medical condition: Acquired Cold Urticaria
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009869 Cold urticaria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023057-11 Sponsor Protocol Number: DC02/RUP/3/09 Start Date*: 2011-02-09
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: Efficacy and safety of rupatadine solution in the treatment of Chronic Spontaneous Urticaria (CSU) in paediatric patients (2-11 years old).
    Medical condition: Treatment of Chronic Spontaneous Urticaria (CSU) in paediatric patients (2-11 years old).
    Disease: Version SOC Term Classification Code Term Level
    14.0 10040785 - Skin and subcutaneous tissue disorders 10009159 Chronic urticaria LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-021001-21 Sponsor Protocol Number: SMART-2010-1 Start Date*: 2010-09-27
    Sponsor Name:Allergie-Centrum-Charité
    Full Title: An exploratory, randomised, double-blind, placebo controlled crossover study to assess the efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms
    Medical condition: Mastocytosis is characterized by an excessive increase in the number of mast cells in different tissues. Symptoms result either from organ infiltration or frequently from the release of proinflamma...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052577 Pure dermal mastocytosis LLT
    12.1 10056452 Indolent systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000790-13 Sponsor Protocol Number: BIL-0115-MED Start Date*: 2015-06-10
    Sponsor Name:FAES FARMA, S.A.
    Full Title: A single-centre, randomized, double-blind, crossover, single-dose clinical trial to compare bilastine, desloratadine, rupatadine and placebo in the suppression of wheal and flare induced by intrade...
    Medical condition: ALLERGIC RHINOCONJUNTIVITIS AND CHRONIC URTICARIA
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-005939-15 Sponsor Protocol Number: DC04/RUP/3/08 Start Date*: 2009-02-11
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: Efficacy and safety of rupatadine in persistent allergic rhinitis and health-related quality of life in children age 6-11 years: A randomized, double blind, placebo-controlled clinical trial.
    Medical condition: Persistent Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10034382 Perennial allergic rhinitis LLT
    9.1 10039776 Seasonal allergic rhinitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (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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