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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00796224
First received: November 18, 2008
Last updated: February 1, 2010
Last verified: February 2010
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) [ Time Frame: 1,2,3,4,8,24,48,72 hours postdose ] [ Designated as safety issue: No ]
  • Number of Participants With a Clinical Response [ Time Frame: Days 7,8,9 or 10 ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to 28 days ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796224

Locations
Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica, 0000
Pfizer Investigational Site
San Jose, Costa Rica
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, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
azithromycin, pharmacokinetics, pediatrics

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014