This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Zmax Compared to Augmentin in Sinusitis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00367120
First received: August 21, 2006
Last updated: March 15, 2010
Last verified: March 2010
  Purpose
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.

Condition Intervention Phase
Sinusitis Drug: Azithromycin Extended Release Drug: Amoxicillin/Clavulanate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient reported symptom resolution at day 5

Secondary Outcome Measures:
  • Time to symptom resolution.

Enrollment: 762
Study Start Date: June 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367120

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00367120     History of Changes
Other Study ID Numbers: A0661180
Study First Received: August 21, 2006
Last Updated: March 15, 2010

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Amoxicillin
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017