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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   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).
    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

    Clinical Trial Results:
    A multi-centre, randomised, double blind, placebo-controlled, parallel group, single dose, pilot study of the efficacy of 0.6 mg Amylmetacresol BP (AMC) and 1.2mg 2,4-Dichlorobenzyl alcohol (DCBA) throat lozenges in the relief of sore throat due to upper respiratory tract infection.

    EudraCT number
    Trial protocol
    Global completion date
    04 Mar 2009

    Paediatric regulatory details
    Is the trial part of an agreed EMA paediatric investigation plan?
    Is the trial in scope of article 45 of Regulation (EC) No 1901/2006?
    Is the trial in scope of article 46 of Regulation (EC) No 1901/2006?

    Results information
    Results version number
    This version publication date
    31 Mar 2018
    First version publication date
    04 Nov 2016
    Other versions
    Version creation reason
    • Changes to summary attachments
    Following production of the original Clinical Study Report (CSR) for TH0809 potential issues relating to Good Clinical Practice (GCP) compliance of the study have been highlighted which were not adequately described in the original CSR. Although the Erratum does not change the results of the study, as the full CSR was attached to the EudraCT record it was felt that the Erratum should also be included.
    Summary report(s)
    TH0809 Erratum
    Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03 for further information.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice