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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00645112 |
Purpose
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Otitis Media |
Drug: cefdinir (Omnicef) Drug: azithromycin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment |
| Official Title: | A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media |
| Enrollment: | 357 |
| Study Start Date: | November 2003 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: cefdinir (Omnicef)
oral suspension, 7 mg/kg every 12 hours for 5 days
|
| 2: Active Comparator |
Drug: azithromycin
oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
|
Eligibility| Ages Eligible for Study: | 6 Months to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 30 Study Locations
More Information
| Responsible Party: | Abbott ( Angela M Nilius ) |
| Study ID Numbers: | M03-630 |
| Study First Received: | March 22, 2008 |
| Last Updated: | March 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00645112 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents Anti-Bacterial Agents Cephalosporins Otorhinolaryngologic Diseases Therapeutic Uses Cefdinir |
Azithromycin Otitis Otitis Media Ear Diseases Pharmacologic Actions |