Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Phase 3
Completed
- Conditions
- Otitis Media
- Registration Number
- NCT00360100
- Lead Sponsor
- Pfizer
- Brief Summary
Assess tolerability of different dosing formulations (adult versus pediatric).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Have clinical signs/symptoms of AOM in at least 1 ear
Exclusion Criteria
- Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor
- Previously diagnosed disease(s) of immune function
- Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
- Secondary Outcome Measures
Name Time Method Investigator and Sponsor assessment of clinical response. Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1. Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population. Frequencies of occurrence, by day, of treatment-related vomiting.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇵🇦Ciudad de Panama, Panama