UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039334 |
|---|---|
| Receipt number | R000044741 |
| Scientific Title | A single center cross-sectional study on evaluation of gastric hypersensitivity by measuring gastric pressure and CO2 injection volume under endoscopy |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2020/01/31 07:36:18 |
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Basic information
Public title
A single center cross-sectional study on evaluation of gastric hypersensitivity by gastric function test
Acronym
A single center cross-sectional study on evaluation of gastric hypersensitivity
Scientific Title
A single center cross-sectional study on evaluation of gastric hypersensitivity by measuring gastric pressure and CO2 injection volume under endoscopy
Scientific Title:Acronym
Parallel-group comparative study on evaluation of gastric hypersensitivity
Region
| Japan |
Condition
Condition
Drug-registant functional dyspepsia(FD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of gastric hypersensitivity evaluation by measuring gastric pressure and CO2 injection volume under endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Difference of gastric pressure and CO2 injection volume between drug-resistant FD patients and non-FD patients when their symptoms appear
2. Gastric pressure, cut-off value of CO2 injection volume, sensitivity and specificity of drug-resistant FD 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: Over 20 years old and younger than 80 years old
2. Gender: Both males and females
3. Outpatient
4. Patients who have been diagnosed with FD and their symptoms have not improved by drug therapy
(PPI, prokinetics)
5. Patients who understood study, and provided written consent based on their own will
Key exclusion criteria
1. Patients with malignancy
2. Patients with suspected with active infection
3. Pregnant or possibility of being pregnant, and those who are breath feeding
4. Study participation decided to be contraindicated by the
parson in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Iwakiri |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
k-iwa@nms.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Momma |
Organization
Nippon Medical School
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
eri-momma@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
eri-momma@nms.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 03 | 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
| 2018 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigated whether this system of measuring CO2 injection volume and gastric pressure is useful for evaluating gastric hypersensitivity in drug-resistant FD patients who are strongly suspected to have gastric hypersensitivity.
Management information
Registered date
| 2020 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044741
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
