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Trial record 1 of 1 for:    "Atrophic Rhinitis" | "Botulinum Toxins, Type A"
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Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

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ClinicalTrials.gov Identifier: NCT00732680
Recruitment Status : Terminated (Lead investigator moved to a new medical center; study was stopped when he left.)
First Posted : August 12, 2008
Results First Posted : February 13, 2014
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Empty Nose Syndrome
Atrophic Rhinitis
Intervention Drug: Botulinum Toxin Type A
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  55.6%
>=65 years
4
  44.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)
Hide Description The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.
Time Frame 2 weeks after intervention, 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin Type A
Hide Arm/Group Description 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.
All-Cause Mortality
Botulinum Toxin Type A
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin Type A
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botulinum Toxin Type A
Affected / at Risk (%)
Total   0/9 (0.00%) 
No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rizwan Siwani, MBBS
Organization: Mayo Clinic
Phone: 507-284-9155
EMail: siwani.rizwan@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00732680     History of Changes
Other Study ID Numbers: 08-005015
First Submitted: August 8, 2008
First Posted: August 12, 2008
Results First Submitted: November 13, 2013
Results First Posted: February 13, 2014
Last Update Posted: April 18, 2016