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

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ClinicalTrials.gov Identifier: NCT00796224
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : January 25, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Otitis Media Drug: 60 mg/kg azithromycin ER Drug: 30 mg/kg azithromycin IR Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]
  2. Maximum Observed Plasma Concentration (Cmax) of Azithromycin [ Time Frame: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose ]
  3. 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 ]
  4. Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) [ Time Frame: 1,2,3,4,8,24,48,72 hours postdose ]
  5. Number of Participants With a Clinical Response [ Time Frame: Days 7,8,9 or 10 ]
  6. Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to 28 days ]


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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796224


Locations
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Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica, 0000
Pfizer Investigational Site
San Jose, Costa Rica
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00796224     History of Changes
Other Study ID Numbers: A0661190
First Posted: November 24, 2008    Key Record Dates
Results First Posted: January 25, 2010
Last Update Posted: February 18, 2010
Last Verified: February 2010

Keywords provided by Pfizer:
azithromycin, pharmacokinetics, pediatrics

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