Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
- Registration Number
- NCT01406275
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 363
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatrics patients prescribed amoxicillin and clavulanate Amoxicillin and clavulanate Pediatrics patients prescribed amoxicillin and clavulanate for treatment of diseases other than otitis media during study period
- Primary Outcome Measures
Name Time Method 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 2 months Clinical symptoms after treatment with amoxicillin and clavulanate 2 months
- Secondary Outcome Measures
Name Time Method