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

Pfizer1 site in 1 country99 target enrollmentNovember 2006

ConditionsUpper Respiratory Tract Infection

DrugsAzithromycin SR

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Upper Respiratory Tract Infection
Sponsor: Pfizer
Enrollment: 99
Locations: 1
Primary Endpoint: The primary endpoint is Investigator's Clinical efficacy at Day 8.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

May 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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.

Outcomes

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