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| Sponsored by: |
Samsung Medical Center |
| Information provided by: | Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00381771 |
Purpose
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.
| Condition | Phase |
|
Globus Pharyngeus |
Phase II Phase III |
| Study Type: | Observational |
| Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus |
| Estimated Enrollment: | 390 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | June 2007 |
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)
Eligibility
| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Han-Sin Jeong, M.D. | 82-2-3410-0291 | hansin.jeong@samsung.com |
| Korea, Republic of | |||||
| Samsung Medical Center | Recruiting | ||||
| Seoul, Korea, Republic of, 135-710 | |||||
| Samsung Medical Center |
| Principal Investigator: | Han-Sin Jeong, M.D | Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery |
More Information
| Study ID Numbers: | SMC IRB 2006-01-028 |
| First Received: | September 27, 2006 |
| Last Updated: | May 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00381771 |
| Health Authority: | Korea: Food and Drug Administration |
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