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Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

This study has been terminated.
(Lead investigator moved to a new medical center; study was stopped when he left.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00732680
First received: August 8, 2008
Last updated: December 30, 2013
Last verified: December 2013
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Empty Nose Syndrome
Atrophic Rhinitis
Intervention: Drug: Botulinum Toxin Type A

  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
Botulinum Toxin Type A Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.

Participant Flow:   Overall Study
    Botulinum Toxin Type A  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  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
Botulinum Toxin Type A Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose.

Baseline Measures
    Botulinum Toxin Type A  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     4  
Gender  
[units: participants]
 
Female     4  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures

1.  Primary:   Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)   [ Time Frame: 2 weeks after intervention, 2 months ]


  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
No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rizwan Siwani, MBBS
Organization: Mayo Clinic
phone: 507-284-9155
e-mail: siwani.rizwan@mayo.edu


No publications provided


Responsible Party: Oren Friedman M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00732680     History of Changes
Other Study ID Numbers: 08-005015
Study First Received: August 8, 2008
Results First Received: November 13, 2013
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board