UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030312 |
|---|---|
| Receipt number | R000034618 |
| Scientific Title | Epidemiology observational study of the onset frequency of hypergastrinemia in the acid-secreting suppressant administration treatment of patients with gastroesophageal reflux disease |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2017/12/08 14:24:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Epidemiology observational study of the onset frequency of hypergastrinemia in the acid-secreting suppressant administration treatment of patients with gastroesophageal reflux disease
Acronym
Epidemiologic studies of the frequency of hypergastrinemia in the GERD treatment
Scientific Title
Epidemiology observational study of the onset frequency of hypergastrinemia in the acid-secreting suppressant administration treatment of patients with gastroesophageal reflux disease
Scientific Title:Acronym
Epidemiologic studies of the frequency of hypergastrinemia in the GERD treatment
Region
| Japan |
Condition
Condition
The GERD patients under treatment with the acid-secreting suppressant
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Frequency of hypergastrinemia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
It is frequency of hypergastrinemia after eight weeks after the start of therapy of the acid-secreting suppressant
Key secondary outcomes
Association of duration of treatment and hypergastrinemia in the acid-secreting suppressant
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
Patients with gastroesophageal reflux disease under treatment by the administration of acid-secreting suppressant
Key exclusion criteria
non
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Funaki Yasuchi |
Organization
Department of Internal Medicine Aichi Medical University
Division name
Division Gastroenterology
Zip code
Address
1-1 Yazakokarimata. Nagakute,Aichi
TEL
0561-62-3311
momomaru@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Funaki Yasuchi |
Organization
Department of Internal Medicine Aichi Medical University
Division name
Division Gastroenterology
Zip code
Address
1-1 Yazakokarimata. Nagakute,Aichi
TEL
0561-62-3311
Homepage URL
momomaru@aichi-med-u.ac.jp
Sponsor or person
Institute
Division Gastroenterology Department of Internal Medicine Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2017 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034618
