UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022851 |
|---|---|
| Receipt number | 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 23:30:27 |
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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
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology | Radiology |
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
| Medicine |
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
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
| 1st name | |
| Middle name | |
| Last name | Kenichi Utano |
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
| 1st name | |
| Middle name | |
| Last name | Kenichi Utano |
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 or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
Tel
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
| 2016 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026325
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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