Last updated: 11/07/2018 13:24:22
A Comparison of the Efficacy and Safety of Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 10 days, Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 5 days, and Augmentin 40/10 mg/kg/day in Divided Doses q8h for 10 days in the Treatment of Acute Otitis Media in Children.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Comparison of the Efficacy and Safety of Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 10 days, Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 5 days, and Augmentin 40/10 mg/kg/day in Divided Doses q8h for 10 days in the Treatment of Acute Otitis Media in Children.
Trial description: A Comparison of the Efficacy and Safety of Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 10 days, Augmentin 45/6.4 mg/kg/day in Divided Doses q12h for 5 days, and Augmentin 40/10 mg/kg/day in Divided Doses q8h for 10 days in the Treatment of Acute Otitis Media in Children.
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:
Hoberman A, Paradise J, Burch D, Valinski W, Hedrick J, Aronovits G, Drehobl M, Rogers JM. Equivalent efficacy and reduced occurrence of diarrhea from a new formulation of amoxicillin/clavulanate potassium (Augmentin®) for treatment of acute otitis media in children. Pediatr Infect Dis J 20(5): 463-470.
Improved Safety Profile of New Pediatric Amoxicillin/Clavulanate in Acute Otitis Media, Aronovitz, G, MD; Hoberman, A, MD; Drehobl, M, MD; Hedrick, J, MD. Atlanta, Georgia; Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania; Centre for Health Care, San Diego, California; Physicians for Children and Adolescents, Bardstown, Kentucky; San Francisco, CA; USA. 35th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). 9/17/1995
Medical condition
Otitis Maedia
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
January 1994 to June 1994
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
1994-20-06
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
Not applicable
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