UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008906 |
|---|---|
| Receipt number | R000010445 |
| Scientific Title | Gastric acid secretion study in Japanese (both elderly and non-elderly subjects) |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2014/03/12 09:29:36 |
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Basic information
Public title
Gastric acid secretion study in Japanese (both elderly and non-elderly subjects)
Acronym
Gastric acid secretion study in Japanese
Scientific Title
Gastric acid secretion study in Japanese (both elderly and non-elderly subjects)
Scientific Title:Acronym
Gastric acid secretion study in Japanese
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease:GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure basal acid output and pentagastrin-stimulated acid output in the elderly and non-elderly Japanese at present and compare the data in the early 1970s and early 1990s (Gut 1997; 41: 452-458)
Basic objectives2
Others
Basic objectives -Others
To measure the basal acid output and maximal acid output separately in elderly (age 65 or over) and non-elderly subjects in each of the H. pylori-negative and H. pylori-positive groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the basal acid output (BAO) and maximal acid output (MAO) separately in elderly (age 65 or over) and non-elderly subjects in each of the H. pylori-negative and H. pylori-positive groups.
Key secondary outcomes
he following parameters will be measured and analyzed:
Serum pepsinogen I and II levels
Fasting serum gastrin levels
Correlation between the fasting serum gastrin and the BAO/MAO
Correlation between the serum pepsinogen and the BAO/MAO
Gastric acid secretion in young subject (H. pylori-negative)
Others
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The volunteers who do not have disorder would be influenced gastric acid secretion and who has provided written informed consent to participate in the study after full written and oral explanations.
Key exclusion criteria
Peptic ulcer
History of gastrointestinal surgery (except for surgery for appendicitis and hemorrhoid)
History of malignant tumor, renal failure, and other gastrointestinal diseases that may affect the study
The use of drugs, including over-the-counter (OTC) drugs that affect gastric acid secretion (except for the as-needed use of drugs that can be discontinued from 2 weeks before gastric acid collection)
History of H. pylori eradication
The use of antithrombogenic drug
The volunteer who is otherwise ineligible for the study in the investigator's opinion
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
kinoshita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
Homepage URL
kinoshita@med.shimane-u.ac.jp
Sponsor or person
Institute
Research Organization for GastroEnterological disease Treatment (ROGET)
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
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
医療法人平心会 大阪治験病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
| 2012 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 02 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
healthy volunteer study
Management information
Registered date
| 2012 | Year | 09 | Month | 12 | Day |
Last modified on
| 2014 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010445
