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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00393835
First received: October 26, 2006
Last updated: May 15, 2008
Last verified: May 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393835

Locations
Japan
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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:
Tonsillitis
Pharyngitis
Respiratory Tract Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Infection
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013