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CompletedNCT00393835Updated May 16, 2008

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

A Phase 3 interventional study of Azithromycin SR in Upper Respiratory Tract Infection, sponsored by Pfizer. Completed at 5 sites in Japan. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-05-16.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
99
Allocation
Non-randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Upper Respiratory Tract Infection
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 99 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
99 participants (actual)

Interventions

  • DrugAzithromycin SR
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. 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

07

Study locations

5 sites
  • Pfizer Investigational Site
    Gobo, Wakayama 644-8655, Japan
  • Pfizer Investigational Site
    Hashimoto, Wakayama 648-0053, Japan
  • Pfizer Investigational Site
    Shinjo-cho, Tanabe, Wakayama 646-8588, Japan
  • Pfizer Investigational Site
    Wakayama, 640-8435, Japan
  • Pfizer Investigational Site
    Wakayama, 641-8510, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00393835
Lead sponsor
Pfizer
First posted
Oct 29, 2006
Start date
Nov 2006
Primary completion
May 2007
Completion
May 2007
Last update
May 16, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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