Globus PharyngeusNCT00381771
Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
An observational study of Globus Pharyngeus, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Globus Pharyngeus
- What is being tested?
- Conservative management for xerostomia
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 340 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Globus phryngeus patients (complaining foreign body sensation in the throat, but not having true mass lesions)
Who may be able to join
- Subjects with globus pharyngeus symptoms
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Group 1: Globus patients with objective salivary hypofunction
- 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)
- Conditions
- Globus Pharyngeus
- Being tested
- Conservative management for xerostomia
- Keywords
- Globus Pharyngeus, Xerostomia, Salivary Hypofunction, Pharyngoxerosis
- Medical subject headings
- Globus Sensation, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative management for xerostomiaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Objective salivary function | Based on the salivary scintigraphy,
1. Objective salivary normo-function
2. Objective salivary dysfunction Receives: Behavioral: Conservative management for xerostomia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startFeb 2006
- Primary completionAug 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Globus PharyngeusStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Han-Sin Jeong, M.D, Principal investigator, Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381771
- Sponsor's protocol ID
- SMC IRB 2006-01-028
- Status last verified
- Jul 2010
- First submitted
- 27 Sep 2006
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19572282
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Salivary Hypofunction in Patients With Globus Pharyngeus
- ClinicalTrials.gov ID
- NCT00381771
- Acronym / sponsor ID
- SMC IRB 2006-01-028
- Conditions
- Globus Pharyngeus
- Keywords
- Globus Pharyngeus, Xerostomia, Salivary Hypofunction, Pharyngoxerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
- Group 1: Globus patients with objective salivary hypofunction
- 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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Objective salivary function | – | Behavioral: Conservative management for xerostomiaBased on the salivary scintigraphy, 1. Objective salivary normo-function 2. Objective salivary dysfunction |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Globus phryngeus patients (complaining foreign body sensation in the throat, but not having true mass lesions)
Key inclusion criteria (1 listed)
- Subjects with globus pharyngeus symptoms
Key exclusion criteria (4 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative management for xerostomiaActive 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. | Behavioural | Objective salivary function |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
- Results publication: PubMed 19572282Baek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Sin Jeong, M.D principal investigator
Samsung Medical Center, Dept of Otorhinolaryngology-Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Globus Pharyngeus, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2010.