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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Participant Flow:   Overall Study
    Intervention Arm     Symptomatic Treatments Only  
STARTED     85     81  
Day -3 Assessment     81     74  
Day 7 Assessment     80     75  
Day 10 Assessment     81     71  
Day 28 Assessment     82     77  
COMPLETED     81 [1]   74 [2]
NOT COMPLETED     4     7  
Unable to contact for telephone intervie                 4                 7  
[1] The number varied by day of follow-up from 80 to 82 in the intervention group.
[2] The number varied by day of follow-up from 71 to 77 in the symptomatic treatment only group.



  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
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Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
    Intervention Arm     Symptomatic Treatments Only  
Total, serious adverse events      
# participants affected / at risk     0/85 (0.00%)     0/81 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
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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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