Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)

Overview

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.)

Full Title of Study: “Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: Amoxicillin and clavulanate

Arms, Groups and Cohorts

  • Pediatrics patients prescribed amoxicillin and clavulanate
    • Pediatrics patients prescribed amoxicillin and clavulanate for treatment of diseases other than otitis media during study period

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 2 months
  • Clinical symptoms after treatment with amoxicillin and clavulanate
    • Time Frame: 2 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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