Last updated: 11/07/2018 13:24:53
A Comparison of the Safety and Efficacy of q 12 hrs Augmentin-90/6.4 mg/kg/day and q 12 hrs Augmentin-45/6.4 mg/kg/day in the Treatment of Acute Otitis Media in Children: A Randomized Double-Blind, Multicenter, Comparative Study.
Clinicaltrials.gov ID
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EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A Comparison of the Safety and Efficacy of q 12 hrs Augmentin-90/6.4 mg/kg/day and q 12 hrs Augmentin-45/6.4 mg/kg/day in the Treatment of Acute Otitis Media in Children: A Randomized Double-Blind, Multicenter, Comparative Study.
Trial description: A Comparison of the Safety and Efficacy of q 12 hrs Augmentin-90/6.4 mg/kg/day and q 12 hrs Augmentin-45/6.4 mg/kg/day in the Treatment of Acute Otitis Media in Children: A Randomized Double-Blind, Multicenter, Comparative Study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
CLINICAL PROFILE OF A NEW FORMULATION OF AMOXICILLIN/CLAVULANATE (A/C) FOR THE TREATMENT OF ACUTE OTITIS MEDIA (AOM), Daniel Burch, George -Aloonsamn@y. The A 011 Collaborative Stu@y Group,- Snüth-Kline Beecham Phariiiaceuticals, Collegeville, PA, USA; Birmingham; UK. 21st International Congress of Chemotherapy. 7/4/1999
Clinical Profile of a New Formulation of Amoxicillin/Clavulanate (A/C) for the Treatment of Acne Otitis Media, Burch, D, MD; McCracken, G, MD; Moonsammy, G, MD; Acne Otitis Media Collaborative Study Group. Southwestern Medical Center, Dallas, Texas; SmithKline Beecham, Collegeville, Pennsylvania; San Francisco, CA; USA. Infectious Diseases Society of America 35th Annual Meeting. 9/13/1997
Safety and tolerability of a new formulation (90 mg/kg/day divided every 12 h) of amoxicillin/clavulanate (augmentin) in the empiric treatment of pediatric acute otitis media caused by drug-resistant streptococcus pneumoniae. Bottenfield, G. W., Burch, D. J., Hedrick, J. A., Schaten, R., Rowinski, C. A., and Davies, J. T. Pediatr Infect Dis J 98; 17(10):963-8
Medical condition
Otitis Maedia
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
December 1996 to February 1997
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1997-28-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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