A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00393835

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 III

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin

Tonsillitis
Stomatognathic Diseases
Pharyngeal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009