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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000022851 |
Receipt No. | R000026325 |
Scientific Title | A markedly reduced-laxative CT colonography: a radormized clinical trial |
Date of disclosure of the study information | 2016/07/01 |
Last modified on | 2019/05/31 |
Basic information | ||
Public title | A markedly reduced-laxative CT colonography: a radormized clinical trial | |
Acronym | Reduced-laxative CTC Study | |
Scientific Title | A markedly reduced-laxative CT colonography: a radormized clinical trial | |
Scientific Title:Acronym | Reduced-laxative CTC Study | |
Region |
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Condition | |||
Condition | colorectal disease | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate an optimal dose of MoviPrep for reduced-laxative CT colonography |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase |
Assessment | |
Primary outcomes | Quality of bowel preparation for CT colonography (size of residual feces, volume of residual liquid, quality of fecal tagging) |
Key secondary outcomes | patient acceptability |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Open -but assessor(s) are blinded |
Control | Dose comparison |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | total dose of MoviPrep 400ml | |
Interventions/Control_2 | total dose of MoviPrep 600ml | |
Interventions/Control_3 | total dose of MoviPrep 800ml | |
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 | Patients suspicious for colorectal diseases, who need colon screening test | |||
Key exclusion criteria | Inflammatory bowel disease, familial adenomatous polyposis, Lynch syndrome, history of bowel resection, GI tract stenosis obstruction or perforation, toxic megacolon. High risk for bowel preparation or CT colonography, pregnancy or its possibility, psychiatric disease or symptom, claustrophobia, serious iodine allergy, thyroidal disease, and others | |||
Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Fukushima Medical University | ||||||
Division name | Aizu Medical Center | ||||||
Zip code | |||||||
Address | Aizuwakamatsu-city, Fukushima | ||||||
TEL | +81-242752100 | ||||||
k-utano@fmu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Fukushima Medical University | ||||||
Division name | Aizu Medical Center | ||||||
Zip code | |||||||
Address | Aizuwakamatsu-city, Fukushima | ||||||
TEL | +81-242752100 | ||||||
Homepage URL | |||||||
k-utano@fmu.ac.jp |
Sponsor | |
Institute | Fukushima Medical University |
Institute | |
Department |
Funding Source | |
Organization | EA pharma |
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 | |
Address | |
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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 | 福島県立医科大学会津医療センター附属病院(福島県) |
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 | |
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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=R000026325 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |