UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030303 |
|---|---|
| Receipt number | R000034518 |
| Scientific Title | Study on gastric emptying by measurement of 13 CO2 concentration during persistent expiration |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2020/12/09 16:03:06 |
* 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
Study on gastric emptying by measurement of 13 CO2 concentration during persistent expiration
Acronym
13CO2 gastric emptying
Scientific Title
Study on gastric emptying by measurement of 13 CO2 concentration during persistent expiration
Scientific Title:Acronym
13CO2 gastric emptying
Region
| Japan |
Condition
Condition
functional dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the pathophysiology of functional dyspepsia patients by objectively evaluating gastric emptying of functional dyspepsia patients.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GEC,Tlag,T1/2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
test meal Ensure H 250mL(375kcal)and 13C
sodium acetate 100mg
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
1) The sex does not matter in 20 years old or more
2) Functional dyspepsia and the patients who had a diagnosis
3) The previous history of treatment does not matter
4) It does not matter to inpatients, the outpatient
5) The patients that an agreement is obtained in a document about participation of this study
Key exclusion criteria
1) The patients that the wearing of the nasal cavity catheter for exclusive use of four hours is impossible
2) The patients who took in a diet and adipose many diets with the stimulant which is extreme overeating, alcohol consumption on the day before gastric emptying measurement
3) The patients (as for the moisture, possible until two hours ago) who were not able to follow that we did not take in a diet for six hours before gastric emptying measurement
4) The patients with a history of sensitivity to Ensure H
5) The patients with allergy to milk protein
6) The patients of the last years of nephrosis, renal failure
7) Heart failure patients who had nausea, vomiting, the diarrhea
8) In addition, the patients who were judged to be inadequate as subject by the judgment of the physici
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Shimoyama |
Organization
Gunma University Hospital
Division name
gastroenterology and hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8137
yshimoyama@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Shimoyama |
Organization
Gunma University Hospital
Division name
gastroenterology and hepatology
Zip code
3718511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8137
Homepage URL
yshimoyama@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Department of clinical investigation and research unit, Gunma University Hospital
Address
-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-8740
gunmaciru-office@umin.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
| 2017 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
No
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
0
Results
Research was discontinued on March 31, 2019 due to difficulty in case registration.
Results date posted
| 2020 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No participants
Participant flow
No
Adverse events
No
Outcome measures
No
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034518
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
