NCT01406275

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.)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

July 26, 2011

Last Update Submit

May 15, 2017

Conditions

Otitis Maedia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Clinical symptoms after treatment with amoxicillin and clavulanate

    2 months

Study Arms (1)

Pediatrics patients prescribed amoxicillin and clavulanate

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

Drug: Amoxicillin and clavulanate

Interventions

Amoxicillin and clavulanateDRUG
Pediatrics patients prescribed amoxicillin and clavulanate

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AmoxicillinClavulanic Acid

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic Acids

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 1, 2011

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 16, 2017

Record last verified: 2017-05