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OpenTrials
Completed

NCT Number: NCT00360100

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

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

Completed

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

3 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Córdoba, Córdoba Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zmax

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2006
First posted
Aug 3, 2006
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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