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Clinical trials for Benzydamine

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 ).  
     
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    13 result(s) found for: Benzydamine. Displaying page 1 of 1.
    EudraCT Number: 2008-002042-38 Sponsor Protocol Number: AAR1/1 Start Date*: 2008-09-10
    Sponsor Name:Zakłady Farmaceutyczne "UNIA" Spółdzielnia Pracy
    Full Title: Multiple site, randomized, prospective, open comparison of new locally used benzydamine product efficacy with reference product in adult patients with acute pharyngitis or tonsillitis which do not ...
    Medical condition: acute pharyngitis and tonsillitis which do not require antbiotic therapy
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-014401-13 Sponsor Protocol Number: 030(B)SC09047 Start Date*: 2009-12-15
    Sponsor Name:ANGELINI
    Full Title: Efficacy and safety of an alcohol-free formulation of 0.15% benzydamine spray in children with sore throat. Randomized, double blind, placebo-controlled study
    Medical condition: sore-throat
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057868 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) AT (Completed) SK (Completed) RO (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2022-003285-20 Sponsor Protocol Number: 030(Z)MD22061 Start Date*: 2023-03-13
    Sponsor Name:Angelini Pharma S.p.A.
    Full Title: Phase IV study comparing the efficacy and safety of an alcohol-free formulation of 0.15% benzydamine hydrochloride spray and benzydamine hydrochloride 3mg lozenges in paediatric patients (6-12 year...
    Medical condition: acute sore throat
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004855 10041367 Sore throat LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-003588-22 Sponsor Protocol Number: TH0504 Start Date*: 2005-11-29
    Sponsor Name:Boots Healthcare International Limited
    Full Title: A single centre, randomised, single (patient) blind, single dose, parallel group exploratory study to compare the efficacy of an 8.75mg flurbiprofen lozenge (Strefen) with a 3mg benzydamine lozenge...
    Medical condition: Sore throat suitable for treatment in an OTC setting.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003257-29 Sponsor Protocol Number: 030(Z)WO19176 Start Date*: 2020-02-25
    Sponsor Name:Angelini S.p.A.
    Full Title: Phase IV study comparing the efficacy and safety of Benzydamine hydrochloride 0,3% oromucosal spray and Benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat.
    Medical condition: acute sore throat
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-003306-32 Sponsor Protocol Number: 030(Z)WO19247 Start Date*: 2021-01-18
    Sponsor Name:Angelini Pharma S.p.A.
    Full Title: Phase IV study on the feasibility of a preventative/therapeutic approach with Benzydamine Oromucosal solution in radiation-induced Oral Mucositis (OM) in patients with head and neck cancer (HNC)
    Medical condition: Oral Mucositis (OM) in patients with head and neck cancer (HNC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10056468 Oral mucosal disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-019953-16 Sponsor Protocol Number: 1009435 Start Date*: 2010-08-31
    Sponsor Name:Royal Devon & Exeter Foundation Trust
    Full Title: A Preliminary Randomised Controlled Trial using Standard Therapy Vs Mugard
    Medical condition: Chemotherapy and radiotherapy induced oral mucositis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-013320-23 Sponsor Protocol Number: 030(H)SC09143 Start Date*: 2009-10-14
    Sponsor Name:ANGELINI
    Full Title: A randomized, double-blind, placebo-controlled trial of benzydamine hydrochloride cream in the treatment of plaque psoriasis: a proof-of-concept and dose-finding study
    Medical condition: mild/severe plaque psorias
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040785 SOC
    9.1 10037153 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002808-19 Sponsor Protocol Number: 030(4C)HO16241 Start Date*: 2017-10-11
    Sponsor Name:A.C.R.A.F. S.p.A. (Aziende Chimiche Riunite Angelini Francesco)
    Full Title: Phase III study to evaluate the efficacy of a novel antimycotic vaginal pessary combination (containing Benzydamine HCl 6 mg and Econazole nitrate 150 mg) in the Treatment of uncomplicated vulvovag...
    Medical condition: Uncomplicated vulvovaginal candidosis (VVC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000054373 10047783 Vulvovaginal candida LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-005007-26 Sponsor Protocol Number: DAM/002/08 Start Date*: 2008-11-04
    Sponsor Name:FARMACEUTICI DAMOR
    Full Title: An open-label, controlled, randomized, prospective, between groups, multicenter clinical trial on the efficacy and safety of Fitostimoline (vaginal cream, vaginal suppositories and vaginal solution...
    Medical condition: Patients with aspecific vaginosis and/or vulvo vaginitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046953 Vaginitis and vulvovaginitis, unspecified LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000278-74 Sponsor Protocol Number: KKL022010 Start Date*: 2011-07-11
    Sponsor Name:KRKA, tovarna zdravil, d. d., Novo mesto
    Full Title: A COMPARATIVE EFFICACY AND SAFETY OF CETYLPYRIDINIUM CHLORIDE 1.0 mg/BENZYDAMINE HYDROCHLORIDE 3 mg FIXED COMBINATION LOZENGES IN SUBJECTS WITH SORE THROAT ASSOCIATED WITH UPPER RESPIRATORY TRACT I...
    Medical condition: Sore throat associated with upper respiratory infections
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10041368 Sore throat NOS LLT
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10068319 Oropharyngeal pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2013-002970-32 Sponsor Protocol Number: KKL072012 Start Date*: 2013-12-23
    Sponsor Name:KRKA, tovarna zdravil, d. d., Novo mesto
    Full Title: A COMPARISON OF THERAPEUTIC EQUIVALENCE BETWEEN THE TEST AND THE REFERENCE FORMULATION OF FIXED COMBINATION OF CETYLPYRIDINIUM CHLORIDE 1.0 mg/BENZYDAMINE HYDROCHLORIDE 3 mg IN SUBJECTS WITH SORE T...
    Medical condition: Sore throat associated with upper respiratory infections
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10041368 Sore throat NOS LLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10068319 Oropharyngeal pain PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2018-004078-89 Sponsor Protocol Number: 0001741 Start Date*: Information not available in EudraCT
    Sponsor Name:DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
    Full Title: RINSING WITH DESAMETASONE VERSUS RINSING WITH BENZIDAMINE IN THE PREVENTION OF MUCOSITES CORRELATED TO CHEMIORADIOTHERAPY IN PATIENTS WITH CANCERS OF THE CERVIC-FACIAL DISTRICT-Studio DEXWASH
    Medical condition: patients with cervico-facial neoplasms receiving concomitant chemoradiotherapy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
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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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