UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030317 |
|---|---|
| Receipt number | R000034621 |
| Scientific Title | Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2017/12/08 16:26:56 |
* 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
Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Acronym
Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Scientific Title
Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Scientific Title:Acronym
Related examination of the serum gastrin level of patients with gastroesophageal reflux disease in the acid-secreting suppressant administration treatment and the intragastric acid kinetics of secretion
Region
| Japan |
Condition
Condition
The acid-secreting suppressant-resistant GERD patients
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the association of the ratio in patients with treated gastroesophageal reflux disease eight weeks or more with PPI and P-CAB standard dose at under intragastric pH 4 time for serum gastrin level and 24 hours.
Basic objectives2
Others
Basic objectives -Others
We perform 24pHMII for the purpose of gastroesophageal reflux dynamics associated with the onset of symptom of subjects and intragastric acid drying effect.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum gastrin level of the acid-secreting suppressant-resistant GERD patients
Key secondary outcomes
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
atients with GERD symptom survival that the patients who gastroesophageal reflux disease was diagnosed in this hospital, and received treatment eight weeks or more with PPI or P-CAB standard dose showed more than two points in GERDQ
Key exclusion criteria
The patients with a history of the following disease or the patients who merge now
Zollinger -Ellison syndrome ,Oesophageal stenosis ,Serious esophagus dyskinesia including the achalasia symptom ,Cerebrovascular disorder such as cerebral hemorrhage, cerebral infarction. The Helicobacter pylori infection history patients.
The patients who have difficulty in participation in this study by a merger with serious hepatic disorder, renal disease, heart disorder .A malignant lesion was confirmed; or is the patients with suspected malignant lesion. A pregnant woman, nursing mother or the woman who may be pregnant .In addition, the patients who judged that clinical studies responsibility physician or the study medical attendant was inadequate
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Funaki Yasushi |
Organization
Department of Intermal Medicine Aichi Medical University
Division name
Division of Gastroenterology
Zip code
Address
1-1Yazakokarimata,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 Yasushi |
Organization
Department of Intermal Medicine Aichi Medical University
Division name
Division of Gastroenterology
Zip code
Address
1-1Yazakokarimata,Nagakute,Aichi
TEL
0561-62-3311
Homepage URL
momomaru@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Intermal Medicine Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Intermal Medicine Aichi Medical University
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 | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | Day |
Last follow-up date
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=R000034621
