Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

Completed

• Conditions: Globus Pharyngeus
• Interventions: Behavioral: Conservative management for xerostomia

• Registration Number: NCT00381771
• Lead Sponsor: Samsung Medical Center

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.

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)

1. Group 1: Globus patients with objective salivary hypofunction

2. 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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Primary Completion: 2007-08
• Study Completion: 2007-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-27
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Objective salivary function	Conservative management for xerostomia	Based on the salivary scintigraphy, 1. Objective salivary normo-function 2. Objective salivary dysfunction

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of