Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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   43871   clinical trials with a EudraCT protocol, of which   7290   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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 require antibiotic therapy

    Summary
    EudraCT number
    		 2008-002042-38
    Trial protocol
    		 PL  
    Global end of trial date
    04 Mar 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 May 2021
    First version publication date
    05 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AAR1/1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zakłady Farmaceutyczne „UNIA” Sp. Pracy
    Sponsor organisation address
    Chłodna 56/60, Warsaw, Poland, 00-872
    Public contact
    Ewa Golańska-Dutka, Zakłady Farmaceutyczne „UNIA” Sp. Pracy, 48 693400000, ewa.golanska@uniapharm.pl
    Scientific contact
    Ewa Golańska-Dutka, Zakłady Farmaceutyczne „UNIA” Sp. Pracy, 48 693400000, ewa.golanska@uniapharm.pl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Mar 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To indicate that new benzydamine hydrochloride product used locally 4 to 6 times daily is equally effective as reference product in acute pharyngitis or tonsillitis in adult patients
    Protection of trial subjects
    Treated in routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Oct 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 109
    Worldwide total number of subjects
    109
    EEA total number of subjects
    109
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    109
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Patients age 18-70 years old from Poland with acute pharyngitis with no need of using antibiotics, lasts form maximum 72 hours.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 109
    Number of subjects completed
    		 109

    Period 1
    Period 1 title
    overal trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Patients with pharyngitis
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Uniben
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray, solution
    Routes of administration
    Oromucosal use
    Dosage and administration details
    5 days, 4-6 times a day

    Number of subjects in period 1
    		Patients with pharyngitis
    Started
    109
    Completed
    109

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overal trial
    Reporting group description
    		 -

    Reporting group values
    		 overal trial Total
    Number of subjects
    		 109 109
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 109 109
    Gender categorical
    Units: Subjects
        Female
    		 66 66
        Male
    		 43 43

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Patients with pharyngitis
    Reporting group description
    		 -

    Primary: intensification of symptoms according to indications

    		 Close Top of page
    End point title
    		 intensification of symptoms according to indications [1]
    End point description
    The severity of the indications was assessed on a five-point symptom severity scale. The sum of the points obtained was defined as the total symptom index and subjected to statistical analysis. The absolute value of this parameter was assessed, as well as its changes in the time of consecutive visits of controls compared to visit 1.
    End point type
    Primary
    End point timeframe
    from first to last visit
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No control group. Statistical analysic was performed on 1 group: Statistical methods: • set significance level p ≤ 0.05 • the normality of the distribution of the assessed parameters was assessed with the Shapiro-Wilk test • statistical inference and comparison of clinical efficacy parameters were performed at p <0.05 using the Wilcoxon and Kolmogorow-Smirnov tests • the comparison of clinical efficacy parameters was carried out using the Wilcoxon and t- Student test
    End point values
    		 Patients with pharyngitis
    Number of subjects analysed
    109
    Units: 1-5
        number (not applicable)
    109
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    During whole trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse drug reaction reported during the time of trial

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 06 02:35:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA