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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00393835
Recruitment Status : Completed
First Posted : October 30, 2006
Last Update Posted : May 16, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infection Drug: Azithromycin SR Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 640-8435
Pfizer Investigational Site
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00393835     History of Changes
Other Study ID Numbers: A0661176
First Posted: October 30, 2006    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Respiratory Tract Infections
Tonsillitis
Infection
Respiratory Tract Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases