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Trial record 16 of 29 for:    Guatemala | Dominican Republic

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360100
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : May 17, 2011
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Brief Summary:
Assess tolerability of different dosing formulations (adult versus pediatric).

Condition or disease Intervention/treatment Phase
Otitis Media Drug: Zmax Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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

Secondary Outcome Measures :
  1. 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.
  2. Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
  3. Frequencies of occurrence, by day, of treatment-related vomiting.
  4. Investigator and Sponsor assessment of clinical response.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00360100

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United States, Kentucky
Pfizer Investigational Site
Bardstown, Kentucky, United States
Pfizer Investigational Site
Springfield, Kentucky, United States
Pfizer Investigational Site
Cordoba, Argentina
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
Pfizer Investigational Site
Ciudad Guatemala, Guatemala
Pfizer Investigational Site
Guatemala, Guatemala
Pfizer Investigational Site
Ciudad de Panama, Panama
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00360100     History of Changes
Other Study ID Numbers: A0661170
First Posted: August 3, 2006    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases