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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000040508 |
Receipt No. | R000046243 |
Scientific Title | Survey on bowel preparation for colonoscopy |
Date of disclosure of the study information | 2020/06/01 |
Last modified on | 2021/02/10 |
Basic information | ||
Public title | Survey on bowel preparation for colonoscopy | |
Acronym | Survey on bowel preparation for colonoscopy | |
Scientific Title | Survey on bowel preparation for colonoscopy | |
Scientific Title:Acronym | Survey on bowel preparation for colonoscopy | |
Region |
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Condition | |||
Condition | Patients scheduled for colonoscopy | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To obtain evidence for a bowel preparation agent that meets the needs of our customers, in order to clarify what is important in pretreatment of colonoscopy for medical professionals (physicians, nurses, technicians) by questionnaire surveys on the Web. |
Basic objectives2 | Others |
Basic objectives -Others | Fact-finding survey |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Importance scores of bowel preparation for colonoscopy by items. |
Key secondary outcomes | Differences between occupations (physicians/nurses/technicians) on the importance score of bowel preparation for colonoscopy by item.
Differences by facility and respondent background on the importance score of bowel preparation for colonoscopy by item. Aggregation of confirmation items before inspection. Aggregation of defecation management before inspection. Aggregation of evaluation of bowel preparation in use. |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | - Physicians, nurses, and technicians performing colonoscopies
- Currently working at a facility that performs more than 20 colonoscopies per month |
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Key exclusion criteria | No specific settings | |||
Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | EA Pharma Co., Ltd. | ||||||
Division name | Associate General Manager (Medical Department) | ||||||
Zip code | 104-0042 | ||||||
Address | 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan | ||||||
TEL | 03-6280-9685 | ||||||
hisanori_masaki@eapharma.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | EA Pharma Co., Ltd. | ||||||
Division name | Associate General Manager (Medical Department) | ||||||
Zip code | 104-0042 | ||||||
Address | 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan | ||||||
TEL | 03-6280-9685 | ||||||
Homepage URL | |||||||
hisanori_masaki@eapharma.co.jp |
Sponsor | |
Institute | EA Pharma Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | EA Pharma Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Yamauchi Clinic IRB |
Address | 1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan |
Tel | 03-5575-5862 |
c-irb_ug@neues.co.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 | |
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 | Completed | ||||||
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 | nothing |
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=R000046243 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |