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| Tracking Information | |||||
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| First Received Date ICMJE | September 27, 2006 | ||||
| Last Updated Date | January 12, 2009 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00381771 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus | ||||
| Official Title ICMJE | Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus | ||||
| Brief Summary | It is well known that 'globus sensation in throat' is caused by the chronic irritation and inflammation of oral, pharyngeal, or laryngeal mucosa, such as laryngopharyngeal reflux and chronic postnasal drip. Xerostomia and pharyngoxerosis due to salivary hypofunction also proved to induce the mucosal change of the oral cavity and pharynx. However, no previous studies have documented the prevalence of salivary hypofunction in patients with globus pharyngeus. Through this clinical investigation, we hypothesized that the salivary hypofunction might be one of the leading cause of globus pharyngeus. |
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| Detailed Description | Subjects: patients with symptoms of globus pharyngeus Globus symptom scoring: 0(mild) to 5(severe) Subjective symptom analysis by "Standard Table for Xerostomia and Pharyngoxerosis" Subjective physical finding analysis by "Standard Table for Xerostomia and Pharyngoxerosis" Objective analysis of Salivary function by 99m-Tc Salivary scintigraphy --> Define the prevalence of salivary hypofunction in patients with globus pharyngeus (Primary end point) Subsequent analysis (Secondary end point)
Intervention: Active management for xerostomia (Moisturizing, Gargling, Humidification, Massage of salivary gland, Stimulant of salivary secretion, Artificial saliva) Evaluation of the change of globus symptoms after active management of xerostomia between the Group 1 and Group 2 (at 1 months, at 3 months after the initiation of intervention) |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Globus Pharyngeus | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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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 | Completed | ||||
| Enrollment ICMJE | 340 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00381771 | ||||
| Responsible Party | Han-Sin Jeong, Pf, Samsung Medical Center | ||||
| Study ID Numbers ICMJE | SMC IRB 2006-01-028 | ||||
| Study Sponsor ICMJE | Samsung Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Samsung Medical Center | ||||
| Verification Date | January 2008 | ||||
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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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