UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051547 |
|---|---|
| Receipt number | R000058087 |
| Scientific Title | Evaluation of intestinal peristalsis with oral drugs that inhibit gastrointestinal peristalsis. |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2023/07/07 16:22:35 |
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Basic information
Public title
Evaluation of intestinal peristalsis with oral drugs that inhibit gastrointestinal peristalsis.
Acronym
Evaluation of intestinal peristalsis with oral drugs that inhibit gastrointestinal peristalsis.
Scientific Title
Evaluation of intestinal peristalsis with oral drugs that inhibit gastrointestinal peristalsis.
Scientific Title:Acronym
Evaluation of intestinal peristalsis with oral drugs that inhibit gastrointestinal peristalsis.
Region
| Japan |
Condition
Condition
Functional gastrointestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use external abdominal ultrasonography or breath test to evaluate intestinal peristalsis before and after oral administration of Shakuyakukanzoto and other drugs to assess their effects on the intestinal contractions.
Basic objectives2
Others
Basic objectives -Others
The change of intestinal peristalsis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of changes in peristalsis before and after oral administration of Shakuyakukanzoto and oter drugs by external abdominal ultrasonography
Key secondary outcomes
Measure the intestinal diameter (maximum diameter) by measuring the diameter of the intestinal tract drawn in the longitudinal direction before and after taking drug.
Evaluate the elevated values of hydrogen and methane gas concentrations by breath test results.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Abdominal ultrasound or breath test
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
Adults with abdominal discomfort or patients taking drugs that inhibit gastrointestinal peristalsis.
Key exclusion criteria
1) obvious infection or inflammation, , 2) serious complications (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, diabetes mellitus that is difficult to control, renal failure, liver cirrhosis), 3) postoperative inflammatory bowel disease of esophagus, stomach, duodenum, or large intestine, 4) deemed by the physician to be inappropriate for this study, 5) Under 20 years old
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Inoue |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515111
keninoue71@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
65, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
0752515111
Homepage URL
reipanna@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee of the Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
0752515337
rinri@koto.kpu-m.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
| 2023 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058087
| 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 |
