Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00360100
First received: August 2, 2006
Last updated: May 16, 2011
Last verified: May 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Assess tolerability of different dosing formulations (adult versus pediatric).
| Condition | Intervention | Phase |
|---|---|---|
|
Otitis Media |
Drug: Zmax |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
Secondary Outcome Measures:
- 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.
- Investigator and Sponsor assessment of clinical response.
| Enrollment: | 120 |
| Study Start Date: | August 2006 |
| Study Completion Date: | December 2006 |
Eligibility| Ages Eligible for Study: | 3 Months to 48 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360100
Locations
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Bardstown, Kentucky, United States | |
| Pfizer Investigational Site | |
| Springfield, Kentucky, United States | |
| Argentina | |
| Pfizer Investigational Site | |
| Cordoba, Argentina | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile | |
| Pfizer Investigational Site | |
| Independencia, Santiago, Chile | |
| Pfizer Investigational Site | |
| Providencia, Santiago, Chile | |
| Costa Rica | |
| Pfizer Investigational Site | |
| San Jose, Costa Rica | |
| Dominican Republic | |
| Pfizer Investigational Site | |
| Santo Domingo, DN, Dominican Republic | |
| Guatemala | |
| Pfizer Investigational Site | |
| Ciudad Guatemala, Guatemala | |
| Pfizer Investigational Site | |
| Guatemala, Guatemala | |
| Panama | |
| Pfizer Investigational Site | |
| Ciudad de Panama, Panama | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
| ClinicalTrials.gov Identifier: | NCT00360100 History of Changes |
| Other Study ID Numbers: | A0661170 |
| Study First Received: | August 2, 2006 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013