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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004005
Receipt No. R000004689
Scientific Title A study on the esophageal sensitivity to acid and carbonated water by modified acid perfusion test and carbonated water perfusion test in healthy volunteers and patients with gastroesophageal reflux disease
Date of disclosure of the study information 2010/08/06
Last modified on 2012/04/01

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Basic information
Public title A study on the esophageal sensitivity to acid and carbonated water by modified acid perfusion test and carbonated water perfusion test in healthy volunteers and patients with gastroesophageal reflux disease
Acronym Esophageal sensitivity test to acid and carbonated water
Scientific Title A study on the esophageal sensitivity to acid and carbonated water by modified acid perfusion test and carbonated water perfusion test in healthy volunteers and patients with gastroesophageal reflux disease
Scientific Title:Acronym Esophageal sensitivity test to acid and carbonated water
Region
Japan

Condition
Condition Gastroesophageal reflux disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the difference in the sensitivity of the esophagus to acid and carbonated water in healthy volunteers and patients with gastroesophageal reflux disease
Basic objectives2 Others
Basic objectives -Others Symptomatology
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the digestive symptom (Visual analogue scale) during the perfusion test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Food Other
Interventions/Control_1 Distilled water and acid perfusion(More than 1 week)Distilled water and carbonated water perfusion
Interventions/Control_2 Distilled water and carbonated water perfusion(More than 1 week)Distilled water and acid perfusion
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Healthy volunteers and patients with gastroesophageal reflux disease more than 18 years-old
2)Subjects with written informed consent
Key exclusion criteria 1)Allegy for lidocaine
2)Past history of gastrectomy
3)The person who catch a clinically improper disease before study starting within 2 weeks
4)Severe diseases in heart, kidney, liver, nerve, digestive system,or severe mental disorder
5)other not applicable person recognized by a doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University Faculty of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 89-1, Enya, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2190
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Furuta
Organization Shimane University Faculty of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 89-1, Enya, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2190
Homepage URL
Email

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Donation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 08 Month 06 Day
Last modified on
2012 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004689

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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