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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Otitis Maedia

Treatments: Drug: Amoxicillin and clavulanate

Study type: Observational

Funder types: Industry

Identifiers

NCT01406275

112283

Details and patient eligibility

About

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.)

Enrollment: 363 patients

Sex: All

Ages: Under 14 years old

Volunteers: No 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

Trial design

363 participants in 1 patient group

Pediatrics patients prescribed amoxicillin and clavulanate

Description:

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

Treatment:

Drug: Amoxicillin and clavulanate