Zmax Compared to Augmentin in Sinusitis

NCT00367120

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sinusitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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SinusitisZmax Compared to Augmentin in Sinusitis
NCT00367120
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Advanced Information
Descriptive Information
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
  • Drug: Azithromycin Extended Release
  • Drug: Amoxicillin/Clavulanate
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
 (submitted: March 15, 2010)
762
Original Enrollment  ICMJE
 (submitted: August 21, 2006)
720
Actual Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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