Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
NCT00360100
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Have clinical signs/symptoms of AOM in at least 1 ear
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media | |||
| Official Title ICMJE | A Randomized, Multicenter, Comparative Study To Assess Tolerability Of A Single Oral 60 Mg/Kg Dose Of Zmax (Pediatric Concentration) Vs. Zmax (Adult Concentration) In Pediatric Patients With Acute Otitis Media | |||
| Brief Summary | Assess tolerability of different dosing formulations (adult versus pediatric). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Otitis Media | |||
| Intervention ICMJE | Drug: Zmax | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 120 | |||
| Original Enrollment ICMJE | 100 | |||
| Actual Study Completion Date ICMJE | December 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 3 Months to 48 Months (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Argentina, Chile, Costa Rica, Dominican Republic, Guatemala, Panama, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00360100 | |||
| Other Study ID Numbers ICMJE | A0661170 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||