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Zmax Compared to Augmentin in Sinusitis

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ClinicalTrials.gov Identifier: NCT00367120
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Pfizer

August 21, 2006
August 22, 2006
March 16, 2010
June 2006
Not Provided
Patient reported symptom resolution at day 5
Same as current
Complete list of historical versions of study NCT00367120 on ClinicalTrials.gov Archive Site
Time to symptom resolution.
Same as current
Not Provided
Not Provided
 
Zmax Compared to Augmentin in Sinusitis
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Sinusitis
  • Drug: Azithromycin Extended Release
  • Drug: Amoxicillin/Clavulanate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
762
720
February 2007
Not Provided

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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00367120
A0661180
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP