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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01406275

Enrollment

363

Registered

2011-08-01

Start date

2008-01-31

Completion date

2008-12-31

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Maedia

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.)

Interventions

DRUGAmoxicillin and clavulanate

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical symptoms after treatment with amoxicillin and clavulanate	2 months
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026