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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000042969 |
Receipt No. | R000049054 |
Scientific Title | Study on the change of gastric emptying ability by vonoprazan |
Date of disclosure of the study information | 2021/01/12 |
Last modified on | 2021/01/11 |
Basic information | ||
Public title | Study on the change of gastric emptying ability by vonoprazan
Study on changes in gastric emptying ability due to suppression of acid secretion |
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Acronym | Study on the change of gastric emptying ability by vonoprazan | |
Scientific Title | Study on the change of gastric emptying ability by vonoprazan | |
Scientific Title:Acronym | Study on the change of gastric emptying ability by vonoprazan | |
Region |
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Condition | ||
Condition | functional gastrointestinal disorder | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To determine how vonoprazan treatment alters gastric emptying capacity in healthy subjects. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | gastric emptying breath test |
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 | Self control |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | gastric emptying 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Asymptomatic adults aged 20 to 75 years who participated in UMIN000039199. | |||
Key exclusion criteria | Those who have symptoms of gastric acid reflux or gastric motility insufficiency. Patients with a history of gastrectomy. Patients with active malignancy. Patients with serious complications (heart failure, renal failure, liver failure, respiratory failure, intestinal obstruction) that make it difficult to perform the test. Patients with active gastric ulcer. Patients on dialysis. Pregnant or nursing mothers. Patients with swallowing dysfunction. Those who are allergic to bonoprazan. Patients who cannot express their own will due to dementia or impaired consciousness. Those who are unable to give their consent. Those who are judged as unsuitable as test subjects by the principal investigator (sub-investigator). | |||
Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka Medical College | ||||||
Division name | Second Department of Internal Medicine | ||||||
Zip code | 569-8686 | ||||||
Address | 2-7, Daigaku-machi, Takatsuki-City, Osaka | ||||||
TEL | 072-683-1221 | ||||||
higuchi@osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka Medical College | ||||||
Division name | Second department of internal medicine | ||||||
Zip code | 569-8686 | ||||||
Address | 2-7, Daigaku-machi, Takatsuki-City, Osaka | ||||||
TEL | 072-683-1221 | ||||||
Homepage URL | |||||||
in2112@osaka-med.ac.jp |
Sponsor | |
Institute | Second Department of Internal Medicine, Osaka Medical College |
Institute | |
Department |
Funding Source | |
Organization | Second Department of Internal Medicine, Osaka Medical College |
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 College |
Address | 2-7, Daigaku-Machi, Takatsuki-City, Osaka |
Tel | 072-683-1221 |
omc_rinsyou@osaka-med.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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 10 |
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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049054 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |