Last updated: 11/07/2018 13:28:12
A Randomized, Investigator-Blind, Multicenter Study to Assess the Efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 Days Versus Oral Zithromax Once Daily for 5 Days in the Treatment of Acute Otitis Media in Infants and 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 Randomized, Investigator-Blind, Multicenter Study to Assess the Efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 Days Versus Oral Zithromax Once Daily for 5 Days in the Treatment of Acute Otitis Media in Infants and Children.
Trial description: A Randomized, Investigator-Blind, Multicenter Study to Assess the Efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 Days Versus Oral Zithromax Once Daily for 5 Days in the Treatment of Acute Otitis Media in Infants and 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, Dagan R, Lebovits E, Rosenblut A, Johnson CE, Huff A, Bandekar R, Wynne B. Extra-strength amoxicillin/clavulanate versus azithromycin for the treatment of bacterial acute otitis media in children. Abstracts from the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy 2003; Abstract G-459, p 279.
Hoberman A, Dagan R, Lebovits E, Rosenblut A, Johnson CE, Huff A, Bandekar R, Wynne B. Large Dosage Amoxicillin/Clavulanate, Compared With Azithromycin, for the Treatment of Bacterial Acute Otitis Media in Children. Pediatric Infectious Disease Journal. 24(6):525-532, June 2005.
Medical condition
Otitis Maedia
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
April 2001 to November 2002
Type
Not applicable
Phase
4
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
Clinical study report
Available language(s): English
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
2002-19-11
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website