ABOUT THIS STUDY
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1-800-718-1021
- 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.
- 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;
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Descriptive Information | ||||
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Brief Title ICMJE | Zmax Compared to Augmentin in Sinusitis | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Sinusitis | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 762 | |||
Original Enrollment ICMJE | 720 | |||
Actual Study Completion Date ICMJE | February 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00367120 | |||
Other Study ID Numbers ICMJE | A0661180 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |