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

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ClinicalTrials.gov Identifier: NCT01406275
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.)


Condition or disease Intervention/treatment
Otitis Maedia Drug: Amoxicillin and clavulanate

Study Design
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Study Type : Observational
Actual Enrollment : 363 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Clinical symptoms after treatment with amoxicillin and clavulanate [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406275


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01406275     History of Changes
Other Study ID Numbers: 112283
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
 Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action