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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007417
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006270

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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