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Sinuclean's Treatment Of Sinusitis' Symptoms (SToSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galsor S.r.l.
ClinicalTrials.gov Identifier:
NCT00747747
First received: September 4, 2008
Last updated: March 12, 2012
Last verified: March 2012
Results First Received: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sinusitis
Interventions: Biological: Saline solution
Device: Sinuclean DM Spray

  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
Period of recruitment: Nov 2007 - Mar 2009 Location: Outpatients attending medical visits by General Practitioners

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
Control No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
Saline Treated. Saline solution sprayed three times in each nostril, twice a day (morning – evening)
Sinuclean Treated. Sinuclean sprayed three times in each nostril, twice a day (morning – evening)

Participant Flow:   Overall Study
    Control     Saline Treated.     Sinuclean Treated.  
STARTED     14     14     21  
COMPLETED     14 [1]   14 [2]   21 [3]
NOT COMPLETED     0     0     0  
[1] 13 with acute episode + 1 with recurrent episode
[2] 11 with acute episode + 3 with recurrent episode
[3] 17 with acute episode + 4 with recurrent episode



  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.
No text entered.

Reporting Groups
  Description
Control No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
Saline Treated. Saline solution sprayed three times in each nostril, twice a day (morning – evening)
Sinuclean Treated. Sinuclean sprayed three times in each nostril, twice a day (morning – evening)
Total Total of all reporting groups

Baseline Measures
    Control     Saline Treated.     Sinuclean Treated.     Total  
Number of Participants  
[units: participants]
  14     14     21     49  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     14     14     21     49  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 15     45  ± 11     48  ± 13     47  ± 13  
Gender  
[units: participants]
       
Female     8     5     11     24  
Male     6     9     10     25  
Region of Enrollment  
[units: participants]
       
Italy     14     14     21     49  



  Outcome Measures
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1.  Primary:   Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)   [ Time Frame: After one week ]

2.  Primary:   Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)   [ Time Frame: After two weeks ]

3.  Secondary:   FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject   [ Time Frame: After one week ]

4.  Secondary:   FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject   [ Time Frame: After two weeks ]

5.  Secondary:   Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)   [ Time Frame: After one week ]

6.  Secondary:   Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)   [ Time Frame: After two weeks ]


  Serious Adverse Events


  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
Clinical diagnosis could not be confirmed before treatment start due to logistics problems to make cranial MRI in due time.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sandro Soriano/Director of Clinical Trials
Organization: Galsor s.r.l.
phone: 0039 0827 601723
e-mail: sandro.soriano@galsor.it


No publications provided


Responsible Party: Galsor S.r.l.
ClinicalTrials.gov Identifier: NCT00747747     History of Changes
Other Study ID Numbers: GAL-01-2007, EudraCT: 2007-003739-22
Study First Received: September 4, 2008
Results First Received: December 5, 2011
Last Updated: March 12, 2012
Health Authority: Italy: The Italian Medicines Agency