Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00381771
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : July 28, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment
Globus Pharyngeus Behavioral: Conservative management for xerostomia

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)


Layout table for study information
Study Type : Observational
Actual Enrollment : 340 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Study Start Date : February 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Group/Cohort Intervention/treatment
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.





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381771


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Han-Sin Jeong, M.D Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery

Publications of Results:
Layout table for additonal information
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
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Conversion Disorder
Somatoform Disorders
Mental Disorders