NCT00381771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

Enrollment Period

1.5 years

First QC Date

September 27, 2006

Last Update Submit

July 27, 2010

Conditions

Keywords

Globus PharyngeusXerostomiaSalivary HypofunctionPharyngoxerosis

Study Arms (1)

Objective salivary function

Based on the salivary scintigraphy, 1. Objective salivary normo-function 2. Objective salivary dysfunction

Behavioral: Conservative management for xerostomia

Interventions

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.

Objective salivary function

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subjects with globus pharyngeus symptoms

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Baek CH, Chung MK, Choi JY, So YK, Son YI, Jeong HS. Role of salivary function in patients with globus pharyngeus. Head Neck. 2010 Feb;32(2):244-52. doi: 10.1002/hed.21176.

MeSH Terms

Conditions

Globus SensationXerostomia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Conversion DisorderSomatoform DisordersMental DisordersSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Han-Sin Jeong, M.D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 28, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

July 28, 2010

Record last verified: 2010-07

Locations