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Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

This study is currently recruiting participants.
Verified by Samsung Medical Center, May 2007

Sponsored by: 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

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Longitudinal, Defined Population, Prospective Study
Official Title:   Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

Further study details as provided by Samsung Medical Center:

Estimated Enrollment:   390
Study Start Date:   February 2006
Estimated Study Completion Date:   June 2007

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)

  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

Contacts
Contact: Han-Sin Jeong, M.D.     82-2-3410-0291     hansin.jeong@samsung.com    

Locations
Korea, Republic of
Samsung Medical Center     Recruiting
      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

Study ID Numbers:   SMC IRB 2006-01-028
First Received:   September 27, 2006
Last Updated:   May 15, 2007
ClinicalTrials.gov Identifier:   NCT00381771
Health Authority:   Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Globus Pharyngeus  
Xerostomia  
Salivary Hypofunction  
Pharyngoxerosis  

Study placed in the following topic categories:
Conversion disorder
Mental Disorders
Somatoform Disorders
Conversion Disorder
Hysteria
Xerostomia

ClinicalTrials.gov processed this record on September 04, 2008




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