Treatment of Acute Sinusitis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00377403
First received: September 14, 2006
Last updated: December 24, 2012
Last verified: December 2012
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Respiratory Infections
Acute Rhinosinusitis
Interventions: Drug: Acetaminophen
Drug: Amoxicillin
Drug: Dextromethorphan hydrobromide with guaifenesin
Drug: Guaifenesin
Drug: Pseudoephedrine Sustained Action
Drug: Saline spray (0.65%)

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intervention Arm Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
Symptomatic Treatments Only Placebo for 10 days in addition to symptomatic treatments
Total Total of all reporting groups

Baseline Measures
    Intervention Arm     Symptomatic Treatments Only     Total  
Number of Participants  
[units: participants]
  85     81     166  
Age  
[units: years]
Median ( Full Range )
  32  
  ( 18 to 69 )  
  31  
  ( 18 to 66 )  
  32  
  ( 18 to 69 )  
Gender  
[units: participants]
     
Female     54     52     106  
Male     31     29     60  



  Outcome Measures

1.  Primary:   SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3   [ Time Frame: 4 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information