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

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01406275

First received: July 26, 2011

Last updated: July 28, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2011

Last Updated Date

July 28, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Clinical symptoms after treatment with amoxicillin and clavulanate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Biospecimen

Sampling Method

Probability Sample

Study Population

Japanese pediatric patients who have superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis other than otitis media, and treated with amoxicillin and clavulanate

Condition ^ICMJE

Otitis Maedia

Intervention ^ICMJE

Drug: Amoxicillin and clavulanate

Study Group/Cohort (s)

Pediatrics patients prescribed amoxicillin and clavulanate

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

Intervention: Drug: Amoxicillin and clavulanate

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

363

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT01406275

Other Study ID Numbers ^ICMJE

112283

Has Data Monitoring Committee

Responsible Party

Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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