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

Phase 3

Completed

• Conditions: Upper Respiratory Tract Infection

• Registration Number: NCT00393835
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-10-26
• Study First Submitted QC: 2006-10-26
• Study First Posted: 2006-10-29
• Study Start: 2006-11
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-15
• Last Update Posted: 2008-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Wakayama, Japan