Last updated: 11/07/2018 04:38:24

Special Drug Use Investigation for CLAVAMOX® (amoxicillin/clavulanate) Pediatrics Dry Syrup (every indication excluded otitis media)

GSK study ID
112283
See study documents
Clinicaltrials.gov ID
NCT01406275
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Special Drug Use Investigation for CLAVAMOX® (amoxicillin/clavulanate) Pediatrics Dry Syrup (every indication excluded otitis media)
Trial description: This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.
("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The number of incidence of adverse events in Japanese pediatric patients, with diseases other than otitis media, treated with amoxicillin and clavulanate based on prescribing information

Timeframe: 2 months

Clinical symptoms after treatment with amoxicillin and clavulanate

Timeframe: 2 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Amoxicillin and clavulanate
    • Enrollment:
    363
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Kazunobu Ouchi, Satoshi Iwata, Hideyuki Okano, Hiroharu Abe. Specific Postmarketing Study of Clavulanic Acid/Amoxicillin (1:14) Dry Syrup for Pediatric in Pediatric Patients with Infection. [Jpn J Chemother]. 2009;57(5):438-452.
    Medical condition
    Otitis Maedia
    Product
    amoxicillin, amoxicillin/clavulanic acid, clavulanic acid
    Collaborators
    Not applicable
    Study date(s)
    January 2008 to April 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable N/A - 14 years
    Accepts healthy volunteers
    No
    • Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis
    Exclusion criteria:
    • Not applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-10-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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