- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381771
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
- Group 1: Globus patients with objective salivary hypofunction
- Group 2: Globus patients with normal salivary function
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)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects with globus pharyngeus symptoms
Exclusion Criteria:
- Subjects with tumors in oral cavity, oropharynx, nasopharynx, hypopharynx, which may cause globus symptoms
- subjects, who do not undergo the endoscopic exam for the upper aerodigestive tract including oral cavity, oropharynx, nasopharynx, hypopharynx.
- subjects, who take medications that may have potential effect on the mucosa of the upper aerodigestive tract including oral cavity, oropharynx, nasopharynx, hypopharynx.
- subjects with poor medical performance (<70%)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Objective salivary function
Based on the salivary scintigraphy,
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Active hydration (drinking more than 10 cups of water per day), Humidification, Oral gargle with a diluted (0.05% to 0.1%) chlorhexidine solution, Sugarless chewing gum, Saliva-stimulating sour juice (sugarless orange juice), Commercial artificial saliva, Nasal saline spray 3 to 4 times a day, Warm massage of the 4 major salivary glands.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Han-Sin Jeong, M.D, Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC IRB 2006-01-028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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