UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005496 |
|---|---|
| Receipt number | R000006518 |
| Scientific Title | The Esophageal Dysfunction Plays a Key Role in the Pathogenesis of Globus sensation |
| Date of disclosure of the study information | 2011/04/24 |
| Last modified on | 2012/03/01 16:39:09 |
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Basic information
Public title
The Esophageal Dysfunction Plays a Key Role in the Pathogenesis of Globus sensation
Acronym
Relation between Globus sensation and the Esophageal Dysfunction
Scientific Title
The Esophageal Dysfunction Plays a Key Role in the Pathogenesis of Globus sensation
Scientific Title:Acronym
Relation between Globus sensation and the Esophageal Dysfunction
Region
| Japan |
Condition
Condition
globus sensation
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with gastroesophageal reflux disease (GERD) have a variety of symptoms such as extraesophageal symptoms. Although Laryngopharyngeal reflux disease (LPRD) is a subtype of GERD that is associated with dysphagia and/or globus sensation, the empiric proton pump inhibitor (PPI) treatment had disappointing results. The aim of this study was to evaluate characteristic pattern of esophageal motility in patients with globus sensation complaining of globus sensation and/or dysphagia who were resistant to PPI treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Globus sensation and/or dysphagia were enrolled. All patients underwent both the larygoscopy and the upper gastrointestinal endoscopy to exclude organic diseases. We investigated the esophageal motility of them by the combined multichannel intraluminal impedance and manometry (MII-EM) for PPI resistant globus sensation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
50 Healtuy volunteer as control and
From Feburary 2011 to Feburary 2013, 50 patients with globus sensation and/or dysphagia were enrolled.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with globus sensation and/or dysphasia
Key exclusion criteria
All patients underwent both the larygoscopy and the upper gastrointestinal endoscopy to exclude organic diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Manabe |
Organization
Kawasaki Medical School
Division name
Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address
577 Matsushima_ Kurashiki_ Okayama_701-0192 Japan
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Manabe |
Organization
Kawasaki Medical School
Division name
Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address
577 Matsushima_ Kurashiki_ Okayama_701-0192 Japan
TEL
Homepage URL
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山県 川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 24 | Day |
Last modified on
| 2012 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006518
