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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00644943 |
Purpose
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Otitis Media |
Drug: cefdinir (Omnicef) Drug: amoxicillin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator) |
| Official Title: | A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media |
| Enrollment: | 425 |
| Study Start Date: | February 2003 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: cefdinir (Omnicef)
oral suspension (7 mg/kg, ql2hr) for 5 days
|
| 2: Active Comparator |
Drug: amoxicillin
oral suspension (45 mg/kg/day, q l2 hours) for 10 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 32 Study Locations
More Information
| Responsible Party: | Abbott ( Angela M Nilius, Ph.D. ) |
| Study ID Numbers: | M02-541 |
| Study First Received: | March 21, 2008 |
| Last Updated: | March 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00644943 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cephalosporins Anti-Infective Agents Amoxicillin Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Cefdinir Otitis Media Enzyme Inhibitors |
Amoxicillin-Potassium Clavulanate Combination Ear Diseases Pharmacologic Actions Anti-Bacterial Agents Otitis Clavulanic Acid Therapeutic Uses |