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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: October 26, 2006
Last updated: May 15, 2008
Last verified: May 2008

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.

Condition Intervention Phase
Upper Respiratory Tract Infection
Drug: Azithromycin SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint is Investigator's Clinical efficacy at Day 8.

Secondary Outcome Measures:
  • 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

Enrollment: 99
Study Start Date: November 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00393835

Pfizer Investigational Site
Gobo, Wakayama, Japan, 644-8655
Pfizer Investigational Site
Hashimoto, Wakayama, Japan, 648-0053
Pfizer Investigational Site
Shinjo-cho, Tanabe, Wakayama, Japan, 646-8588
Pfizer Investigational Site
Wakayama, Japan, 641-8510
Pfizer Investigational Site
Wakayama, Japan, 640-8435
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00393835     History of Changes
Other Study ID Numbers: A0661176
Study First Received: October 26, 2006
Last Updated: May 15, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Stomatognathic Diseases processed this record on November 23, 2014