UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004005 |
|---|---|
| Receipt number | 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 23:49:52 |
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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
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
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004689
