Zmax Compared to Augmentin in Sinusitis

Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367120
• Other study ID #: A0661180
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2006
• Last updated: March 15, 2010
• Start date: June 2006
• Est. completion date: February 2007

Study information

• Verified date: March 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 762
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

Drug:
• Azithromycin Extended Release

• Amoxicillin/Clavulanate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported symptom resolution at day 5
Secondary	Time to symptom resolution.

External Links

•   To obtain contact information for a study center near you, click here.