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

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NCT00360100

Last updated on March 31, 2020
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Study Location
Pfizer Investigational Site
Bardstown, Kentucky, United States
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Contact
1-800-718-1021
[email protected]
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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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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
 (submitted: May 16, 2011) 		120
Original Enrollment  ICMJE
 (submitted: August 2, 2006) 		100
Actual Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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