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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00360100
First received: August 2, 2006
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

Assess tolerability of different dosing formulations (adult versus pediatric).


Condition Intervention Phase
Otitis Media
Drug: Zmax
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.

Secondary Outcome Measures:
  • Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.
  • Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
  • Frequencies of occurrence, by day, of treatment-related vomiting.
  • Investigator and Sponsor assessment of clinical response.

Enrollment: 120
Study Start Date: August 2006
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   3 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00360100

Locations
United States, Kentucky
Pfizer Investigational Site
Bardstown, Kentucky, United States
Pfizer Investigational Site
Springfield, Kentucky, United States
Argentina
Pfizer Investigational Site
Cordoba, Argentina
Chile
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Independencia, Santiago, Chile
Pfizer Investigational Site
Providencia, Santiago, Chile
Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica
Dominican Republic
Pfizer Investigational Site
Santo Domingo, DN, Dominican Republic
Guatemala
Pfizer Investigational Site
Ciudad Guatemala, Guatemala
Pfizer Investigational Site
Guatemala, Guatemala
Panama
Pfizer Investigational Site
Ciudad de Panama, Panama
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
ClinicalTrials.gov Identifier: NCT00360100     History of Changes
Other Study ID Numbers: A0661170
Study First Received: August 2, 2006
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014