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Zmax Compared to Augmentin in Sinusitis

Primary Purpose

Sinusitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Azithromycin Extended Release
Amoxicillin/Clavulanate
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days: Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and Presence of one or more of the following signs: Discolored (yellow-green) nasal discharge Discolored (yellow-green) drainage in the posterior pharynx Discolored (yellow-green) discharge from the maxillary sinus orifice Two or more of the following symptoms are present: Fever, as defined by: Oral temperature: >38C or >100.4F, or Tympanic temperature: >38.5C or >101.2F Frequent coughing Nasal congestion, Post-nasal drainage. Exclusion Criteria: Treatment with any systemic antibiotic within 30 days prior to enrollment Symptoms of sinusitis lasting for longer than 30 days; Four or more episodes of acute sinusitis within the preceding 12 months;

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Patient reported symptom resolution at day 5

    Secondary Outcome Measures

    Time to symptom resolution.

    Full Information

    First Posted
    August 21, 2006
    Last Updated
    March 15, 2010
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00367120
    Brief Title
    Zmax Compared to Augmentin in Sinusitis
    Official Title
    A Multicenter, Randomized, Open Label Comparative Study Of Azithromycin Extended Release (ZMAX) Versus Amoxicillin/Clavulanate Potassium In Subjects With Acute Bacterial Sinusitis (ABS) In A Physician Practice Environment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the study is to compare early resolution of symptoms between the two treatments. Patients will report resolution of their sinusitis symptoms through a daily questionnaire. There will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sinusitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    762 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin Extended Release
    Intervention Type
    Drug
    Intervention Name(s)
    Amoxicillin/Clavulanate
    Primary Outcome Measure Information:
    Title
    Patient reported symptom resolution at day 5
    Secondary Outcome Measure Information:
    Title
    Time to symptom resolution.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days: Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and Presence of one or more of the following signs: Discolored (yellow-green) nasal discharge Discolored (yellow-green) drainage in the posterior pharynx Discolored (yellow-green) discharge from the maxillary sinus orifice Two or more of the following symptoms are present: Fever, as defined by: Oral temperature: >38C or >100.4F, or Tympanic temperature: >38.5C or >101.2F Frequent coughing Nasal congestion, Post-nasal drainage. Exclusion Criteria: Treatment with any systemic antibiotic within 30 days prior to enrollment Symptoms of sinusitis lasting for longer than 30 days; Four or more episodes of acute sinusitis within the preceding 12 months;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661180&StudyName=Zmax+Compared+to+Augmentin+in+Sinusitis
    Description
    To obtain contact information for a study center near you, click here.

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