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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: November 18, 2008
Last updated: February 1, 2010
Last verified: February 2010
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.

Condition Intervention Phase
Acute Otitis Media
Drug: 60 mg/kg azithromycin ER
Drug: 30 mg/kg azithromycin IR
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) [ Time Frame: Predose/0 to 72 Hours ]

Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ]
  • Maximum Observed Plasma Concentration (Cmax) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ]
  • Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) [ Time Frame: 1,2,3,4,8,24,48,72 hours postdose ]
  • Number of Participants With a Clinical Response [ Time Frame: Days 7,8,9 or 10 ]
  • Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to 28 days ]

Enrollment: 38
Study Start Date: December 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1.
60 mg/kg azithromycin ER (Extended Release)arm
Drug: 60 mg/kg azithromycin ER
subjects taken 60 mg/kg azithromycin ER
Other Name: Zithromax
Active Comparator: 2.
30 mg/kg azithromycin IR (Immediate Release) arm
Drug: 30 mg/kg azithromycin IR
subjects taken 30 mg/kg azithromycin IR (Immediate Release)
Other Name: Zithromax


Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00796224

Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica, 0000
Pfizer Investigational Site
San Jose, Costa Rica
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00796224     History of Changes
Other Study ID Numbers: A0661190
Study First Received: November 18, 2008
Results First Received: December 15, 2009
Last Updated: February 1, 2010

Keywords provided by Pfizer:
azithromycin, pharmacokinetics, pediatrics

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 22, 2017