Last updated: 11/07/2018 13:24:11
A comparison of the efficacy, safety and tolerability of Augmentin 60/15 mg/kg/day (4:1 ratio) given po in three divided doses versus Augmentin™ 70/10 mg/kg/day (7:1 ratio) given po in two divided doses in the treatment of children with acute otitis media….
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, safety and tolerability of Augmentin 60/15 mg/kg/day (4:1 ratio) given po in three divided doses versus Augmentin™ 70/10 mg/kg/day (7:1 ratio) given po in two divided doses in the treatment of children with acute otitis media….
Trial description: A comparison of the efficacy, safety and tolerability of Augmentin 60/15 mg/kg/day (4:1 ratio) given po in three divided doses versus Augmentin™ 70/10 mg/kg/day (7:1 ratio) given po in two divided doses in the treatment of children with acute otitis media….
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:
Evaluation of amoxicillin clavulanate twice daily versus thrice daily in the treatment of otitis media in children. danish-swedish study group. Jacobsson, S., Fogh, A., Larsson, P., and Lomborg, S. Eur J Clin Microbiol Infect Dis 93; 12(5):319-24
Medical condition
Otitis Maedia
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
October 1993 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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