Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01032174
Previous Study | Return to List | Next Study

Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis (EASY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01032174
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : March 22, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 14, 2009
First Posted Date December 15, 2009
Results First Submitted Date February 21, 2012
Results First Posted Date March 22, 2012
Last Update Posted Date April 16, 2012
Study Start Date April 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2012)
Percentage of Participants With Response of Very Convenient or Somewhat Convenient [ Time Frame: Day 11 ]
Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.
Original Primary Outcome Measures
 (submitted: December 14, 2009)
The primary efficacy variable will be the percentage of enrolled patients who answer 'very convenient' or 'somewhat convenient' on question 4 of the Treatment Compliance Questionnaire at Visit 3. [ Time Frame: 10 days ]
Change History Complete list of historical versions of study NCT01032174 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 21, 2012)
  • Percent Compliance With Prescribed Treatment Regimen [ Time Frame: Day 11 ]
    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).
  • Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen [ Time Frame: Day 11 ]
    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.
Original Secondary Outcome Measures
 (submitted: December 14, 2009)
Percent compliance with the prescribed treatment regimen, defined as: 100x(number of tablets taken)/(number of tablets prescribed). The percentage of enrolled patients who were 100% compliant with the prescribed treatment regimen. [ Time Frame: 10 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
Official Title Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
Brief Summary The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Acute Maxillary Sinusitis
Condition Maxillary Sinusitis
Intervention
  • Drug: Azithromycin SR
    Azithromycin SR, 2.0 g by mouth (PO) x 1
  • Drug: Amoxiclav 1000 mg
    Amoxiclav 1000 mg x twice daily, 10 days
Study Groups/Cohorts
  • Azithromycin SR
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Azithromycin SR
  • Amoxiclav 1000 mg
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Amoxiclav 1000 mg
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 Completed
Actual Enrollment
 (submitted: June 9, 2011)
123
Original Estimated Enrollment
 (submitted: December 14, 2009)
120
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or nor pregnant or lactating female outpatients, 18 years of age or older.
  • A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:

    1. 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
    2. Presence of one or more of the following signs:

    i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice

  • A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:

    1. complete or partial opacification
    2. an air/fluid level

Two or more of the following:

  1. fever, as defined by temperature: >38ºC
  2. leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;
  3. headache,
  4. nasal congestion and post nasal drainage.

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01032174
Other Study ID Numbers A0661199
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012