Text Size

Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00381771
First received: September 27, 2006
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  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 Intervention Phase
Globus Pharyngeus
 Behavioral: Conservative management for xerostomia
 Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

Resource links provided by NLM:

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

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)
Groups/Cohorts Assigned Interventions
Objective salivary function

Based on the salivary scintigraphy,

  1. Objective salivary normo-function
  2. Objective salivary dysfunction
 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.

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
Sampling Method:   Non-Probability Sample
Study Population

Globus phryngeus patients (complaining foreign body sensation in the throat, but not having true mass lesions)

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

Publications:

Responsible Party: Han-Sin Jeong, Pf, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00381771     History of Changes
Other Study ID Numbers: SMC IRB 2006-01-028
Study First Received: September 27, 2006
Last Updated: July 27, 2010
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Conversion Disorder
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013