Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus - Full Text View

Sponsor:	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:	Case-Only, Prospective
Official Title:	Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

Further study details as provided by Samsung Medical Center:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	340
Study Start Date:	February 2006
Study Completion Date:	December 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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)

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381771

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Han-Sin Jeong, M.D

Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery

More Information

No publications provided

Responsible Party:	Samsung Medical Center ( Han-Sin Jeong, Pf )
Study ID Numbers:	SMC IRB 2006-01-028
Study First Received:	September 27, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00381771 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:

Globus Pharyngeus
Xerostomia
Salivary Hypofunction
Pharyngoxerosis

Additional relevant MeSH terms:

Mental Disorders
Somatoform Disorders
Conversion Disorder

ClinicalTrials.gov processed this record on November 25, 2009