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

NCT ID: NCT01406275

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 363 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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.)

Conditions

Otitis Maedia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatrics patients prescribed amoxicillin and clavulanate

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

Amoxicillin and clavulanate

Intervention Type: DRUG

Interventions

Amoxicillin and clavulanate

Intervention Type: DRUG

Eligibility 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

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112283

Identifier Type: -

Identifier Source: org_study_id