Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

Globus Pharyngeus Clinical Trial

Official title:

Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381771
• Other study ID #: SMC IRB 2006-01-028
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 27, 2006
• Last updated: July 27, 2010
• Start date: February 2006
• Est. completion date: December 2007

Study information

• Verified date: July 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conversion Disorder
• Globus Pharyngeus

Intervention

Behavioral:
• Conservative management for xerostomia
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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation