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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 8, 2008 | ||||||||
| Last Updated Date | June 5, 2009 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, SF36, and IES R scores) and rhinomanometry measurements. [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, BDI-2 score) and rhinomanometry measurements. [ Time Frame: 4 months ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00732680 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome | ||||||||
| Official Title ICMJE | Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome | ||||||||
| Brief Summary | Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates. With this study, we will determine the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of Botox. |
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| Detailed Description | Background: Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain. Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plasti-pore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of Botox Type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow. Objective: To evaluate effectiveness of Botox in improving overall QoL in patients. Methods: 42 subjects will undergo treatment with Botox and adjunctive measures that will involve the use of saline irrigation alongwith sesame oil amongst other measures. Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will help us measure changes in physical and mental health (using the sinonasal outcome test questionnaire or SNOT 22, the short form health survey 36 item questionnaire, and the Impact of events revised scale). Conclusion: We anticipate that Botox application in ENS patients improve overall QoL in these subjects. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Botox | ||||||||
| Study Arms / Comparison Groups | Experimental: Treatment will be in the form of 10 Units of Botox type A injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase. | ||||||||
| Publications * | Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 42 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00732680 | ||||||||
| Responsible Party | Oren Friedman M.D., Mayo Clinic | ||||||||
| Study ID Numbers ICMJE | 08-005015 | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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