Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Otitis Maedia

Eligibility:

All Genders

Up to 14 years

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 Japa...

Eligibility Criteria

Inclusion

  • Pediatric subjects with diseases of superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis and pyelonephritis

Exclusion

  • Not applicable

Key Trial Info

Start Date :

January 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

363 Patients enrolled

Trial Details

Trial ID

NCT01406275

Start Date

January 1 2008

End Date

December 1 2008

Last Update

May 16 2017

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