UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007417 |
|---|---|
| Receipt number | R000006270 |
| Scientific Title | The Esophageal Dysfunction Plays a Key Role in the Pathogenesis of PPI-resistant Globus sensation |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2012/03/01 14:52:43 |
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Basic information
Public title
The Esophageal Dysfunction Plays a Key Role in the Pathogenesis of PPI-resistant Globus sensation
Acronym
PPI-resistant Globus sensation
Scientific Title
The Esophageal Dysfunction Plays a Key Role in the Pathogenesis of PPI-resistant Globus sensation
Scientific Title:Acronym
PPI-resistant Globus sensation
Region
| Japan |
Condition
Condition
dyspahgia and/or globus sensation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigated esophageal motility in GERD patients with globus sensation who were resistant to PPI therapy.
Basic objectives2
Others
Basic objectives -Others
we investigated oesophageal motility in the PPI-resistant group by a multichannel intraluminal impedance and manometry study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The subjects werepatients with globus sensation. All patients underwent both larygoscopy and upper gastrointestinal endoscopy to exclude organic disease. After 4 weeks of treatment with rabeprazole sodium (20 mg daily), the patients were divided into PPI-responsive and PPI-resistant groups. Then we investigated oesophageal motility in the PPI-resistant group by a multichannel intraluminal impedance and manometry study.
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
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
After 4 weeks of treatment with rabeprazole sodium (20 mg daily), the patients were divided into PPI-responsive and PPI-resistant groups. Then we investigated oesophageal motility in the PPI-resistant group by a multichannel intraluminal impedance and manometry study.
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
A total of patients complained of globus sensation were enrolled in this study.
Key exclusion criteria
All patients underwent both larygoscopy and upper gastrointestinal endoscopy to exclude organic disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabe Noriaki |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address
577, Matsushima, Kurashiki, 701-0192
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kawasaki Medical School
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address
577, Matsushima, Kurashiki, 701-0192
TEL
Homepage URL
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 01 | 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
| 2012 | Year | 03 | Month | 01 | 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=R000006270
