A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.

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Key information

Conditions

Upper Respiratory Tract Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Gobō, Wakayama, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Exclusion criteria

Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Treatment and study plan

Azithromycin SR

Drug

Primary outcomes

The primary endpoint is Investigator's Clinical efficacy at Day 8.

Secondary outcomes

Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 4, Day 15 and 29) Bacteriological efficacy (at Day 4, 8, 15 and 29) Safety Endpoints: Adverse events and safety Laboratory data

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin Sustained Release (SR) For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis In Japan Adults

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Oct 30, 2006
Registry last updated: May 16, 2008

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.

Published trials that share one or more normalized conditions with this study.

Completed