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Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
This study has been completed.
Study NCT00381771   Information provided by Samsung Medical Center
First Received: September 27, 2006   Last Updated: January 12, 2009   History of Changes

September 27, 2006
January 12, 2009
February 2006
August 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00381771 on ClinicalTrials.gov Archive Site
 
 
 
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus

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.

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)

Phase II, Phase III
Observational
Case-Only, Prospective
Globus Pharyngeus
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
340
December 2007
August 2007   (final data collection date for primary outcome measure)

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%)
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00381771
Han-Sin Jeong, Pf, Samsung Medical Center
SMC IRB 2006-01-028
Samsung Medical Center
 
Principal Investigator: Han-Sin Jeong, M.D Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery
Samsung Medical Center
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP