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Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
San Jose, , 0000 Costa Rica
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Otitis Media
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-11 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects age 6 months to

- Have clinical signs/symptoms of acute otitis media in at least one ear.

- Parent(s)/legal guardian(s) provide written informed consent.

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

- Clinical significant other disease.

- Recent use of investigational drugs, prescription or nonprescription drugs.

NCT00796224
Pfizer
Completed
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

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Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
A Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Otitis Media
  • Drug: 60 mg/kg azithromycin ER
    subjects taken 60 mg/kg azithromycin ER
    Other Name: Zithromax
  • Drug: 30 mg/kg azithromycin IR
    subjects taken 30 mg/kg azithromycin IR (Immediate Release)
    Other Name: Zithromax
  • Active Comparator: 1.
    60 mg/kg azithromycin ER (Extended Release)arm
    Intervention: Drug: 60 mg/kg azithromycin ER
  • Active Comparator: 2.
    30 mg/kg azithromycin IR (Immediate Release) arm
    Intervention: Drug: 30 mg/kg azithromycin IR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects age 6 months to < 12 years.
  • Have clinical signs/symptoms of acute otitis media in at least one ear.
  • Parent(s)/legal guardian(s) provide written informed consent.

Exclusion Criteria:

  • Clinical significant other disease.
  • Recent use of investigational drugs, prescription or nonprescription drugs.
Sexes Eligible for Study: All
6 Months to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Costa Rica
 
 
NCT00796224
A0661190
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

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

BY EMAIL

Contact

[email protected]



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