NCT00393835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 16, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

October 26, 2006

Last Update Submit

May 15, 2008

Conditions

Upper Respiratory Tract Infection

Outcome Measures

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

Interventions

Azithromycin SRDRUG

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Gobō, Wakayama, 644-8655, Japan

Location

Pfizer Investigational Site

Hashimoto, Wakayama, 648-0053, Japan

Location

Pfizer Investigational Site

Shinjo-cho, Tanabe, Wakayama, 646-8588, Japan

Location

Pfizer Investigational Site

Wakayama, Wakayama, 640-8435, Japan

Location

Pfizer Investigational Site

Wakayama, Wakayama, 641-8510, Japan

Location

Related Links

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

November 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 16, 2008

Record last verified: 2008-05

Locations

JP(5)