Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
1 other identifier
observational
340
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 27, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJuly 28, 2010
July 1, 2010
1.5 years
September 27, 2006
July 27, 2010
Conditions
Keywords
Study Arms (1)
Objective salivary function
Based on the salivary scintigraphy, 1. Objective salivary normo-function 2. Objective salivary dysfunction
Interventions
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.
Eligibility Criteria
Globus phryngeus patients (complaining foreign body sensation in the throat, but not having true mass lesions)
You may qualify if:
- Subjects with globus pharyngeus symptoms
You may not qualify if:
- 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 135-710, South Korea
Related Publications (1)
Baek CH, Chung MK, Choi JY, So YK, Son YI, Jeong HS. Role of salivary function in patients with globus pharyngeus. Head Neck. 2010 Feb;32(2):244-52. doi: 10.1002/hed.21176.
PMID: 19572282RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han-Sin Jeong, M.D
Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 27, 2006
First Posted
September 28, 2006
Study Start
February 1, 2006
Primary Completion
August 1, 2007
Study Completion
December 1, 2007
Last Updated
July 28, 2010
Record last verified: 2010-07