UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004064 |
|---|---|
| Receipt number | R000004785 |
| Scientific Title | Normal values of 24 hour ambulatory simultaneous esophageal impedance and pH monitoring in the Japanese population: a multicenter study |
| Date of disclosure of the study information | 2010/08/21 |
| Last modified on | 2016/08/22 12:50:22 |
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Basic information
Public title
Normal values of 24 hour ambulatory simultaneous esophageal impedance and pH monitoring in the Japanese population: a multicenter study
Acronym
Normal values of 24 hour esophageal impedance and pH monitoring in Japan
Scientific Title
Normal values of 24 hour ambulatory simultaneous esophageal impedance and pH monitoring in the Japanese population: a multicenter study
Scientific Title:Acronym
Normal values of 24 hour esophageal impedance and pH monitoring in Japan
Region
| Japan |
Condition
Condition
Normal Healthy volunteer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish normal values of 24 hour ambulatory simultaneous esophageal impedance and pH monitoring in the Japanese population.
Basic objectives2
Others
Basic objectives -Others
To establish normal values of gastroesophageal reflux in normal healthy Japanese, performing 24 hour ambulatory simultaneous esophageal impedance and pH monitoring in multicenter study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Median value, 25% value and 75% value of number of reflux events of each physical type an of each acidity in the distal esophagus (5 cm above the lower esophageal sphincter (LES))
Mean and SE of %time pH < 4 in the distal esophagus
Key secondary outcomes
Median value, 25% value and 75% value of number of reflux events of each physical type an of each acidity in the proximal esophagus (15 cm above the lower esophageal sphincter (LES))
Median value, 25% value and 75% value of number of superimposed reflux events in the distal esophagus
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No gastrointestinal symptom.
No endoscopic findings in the upper gastrointestinal tract.
Normal healthy subjects.
Key exclusion criteria
Hiatal hernia of more than 2 cm in length.
Organic disease in upper gastrointestinal tract diagnosed by endoscopy.
(Cases more than 1 year after Hp eradication can be included to this study)
Patients with medication of PPI, H2-blocker, Ca antagonist, prokinetics and drug which affect gastrointestinal motility.
History of previous gastrointestinal or thoracic surgery.
Patients with severe heart disease, blood disease, renal disease, liver disease or malignancy.
Pregnant woman or woman with possibility of pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Kaawamura |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-39-15, Showa-machi, Maebashi, Gunma
TEL
027-220-8137
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Kaawamura |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-39-15, Showa-machi, Maebashi, Gunma
TEL
027-220-8137
Homepage URL
osamuk@med.gunma-u.ac.jp
Sponsor or person
Institute
A Society for Impedance study
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
日本医科大学付属病院（東京都）、横浜市立大学附属病院（神奈川県）、名古屋市立大学病院（愛知県）、大阪市立大学医学部附属病院（大阪府）、大阪医科大学附属病院（大阪府）、島根大学医学部附属病院（島根県）、佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 08 | Month | 03 | 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
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2010 | Year | 08 | Month | 18 | Day |
Last modified on
| 2016 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004785
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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