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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004064
Receipt No. 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

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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
Email

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
Email osamuk@med.gunma-u.ac.jp

Sponsor
Institute A Society for Impedance study
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004785

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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