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Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

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NCT00360100

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bardstown, Kentucky, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Otitis Media
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-48 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Have clinical signs/symptoms of AOM in at least 1 ear

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00360100
Pfizer
Completed
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

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Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
NCT00360100
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Multiple Sites
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
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
Assess tolerability of different dosing formulations (adult versus pediatric).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Otitis Media
Drug: Zmax
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2006
Not Provided

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
Sexes Eligible for Study: All
3 Months to 48 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Costa Rica,   Dominican Republic,   Guatemala,   Panama,   United States
 
 
NCT00360100
A0661170
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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