UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046534 |
|---|---|
| Receipt number | R000053099 |
| Scientific Title | Gastric emptying in patients with gastroesophageal reflux disease |
| Date of disclosure of the study information | 2023/04/21 |
| Last modified on | 2023/07/07 09:03:36 |
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Basic information
Public title
Gastric emptying in patients with gastroesophageal reflux disease
Acronym
Gastric emptying in patients with gastroesophageal reflux disease
Scientific Title
Gastric emptying in patients with gastroesophageal reflux disease
Scientific Title:Acronym
Gastric emptying in patients with gastroesophageal reflux disease
Region
| Japan |
Condition
Condition
gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with gastroesophageal reflux disease with symptoms of gastric motility insufficiency, the purpose of this study is to confirm whether gastric peristalsis is truly improved by treatment by measuring gastric evacuation capacity using the 13C breath test method before and after treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric emptying
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Gastric emptying 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with dysmotility symptoms in addition to acid reflux symptoms on the Revised F Scale questionnaire. That is, gastroesophageal reflux symptoms score 4 or more out of 28 points and dyspepsia symptoms score 4 or more out of 28 points.
Key exclusion criteria
Patients with a history of gastrectomy. Patients with active malignancy. Patients with serious complications (cardiac failure, renal failure, hepatic failure, respiratory failure, intestinal obstruction) that make it difficult to perform the test. Patients with active gastric ulcer. Patients on dialysis. Pregnant and lactating patients. Patients with swallowing dysfunction. Patients who are unable to express their own will due to dementia or impaired consciousness. Patients who cannot give their consent. Patients who are judged to be unsuitable as subjects by the principal investigator (submitting physician).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka Medical and Pharmaceutical University
Division name
Second Department of Internal Medicine
Zip code
5698686
Address
2-7, Daigaku-machi, Takatsuki-city
TEL
072-683-1221
kazuhiro.ota@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Ota |
Organization
Osaka Medical and Pharmaceutical University
Division name
Second Department of Internal Medicine
Zip code
5698686
Address
2-7, Daigaku-machi, Takatsuki-city
TEL
072-683-1221
Homepage URL
kazuhiro.ota@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Osaka Medical and Pharmaceutical University
Address
2-7, Daigaku-machi, Takatsuki-city
Tel
072-683-1221
kazuhiro.ota@ompu.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 | 04 | Month | 21 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2022 | Year | 01 | Month | 04 | 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=R000053099
| 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 |
