Last updated: 11/07/2018 04:38:24
Special Drug Use Investigation for CLAVAMOX® (amoxicillin/clavulanate) Pediatrics Dry Syrup (every indication excluded otitis media)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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