UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014668 |
|---|---|
| Receipt number | R000017061 |
| Scientific Title | A Randomized Controlled Trial compares the efficacy of Moviprep vs Muben on the bowel preparation of the patients who undergo colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2014/08/15 |
| Last modified on | 2017/01/28 09:41:10 |
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Basic information
Public title
A Randomized Controlled Trial compares the efficacy of Moviprep vs Muben on the bowel preparation of the patients who undergo colorectal endoscopic submucosal dissection
Acronym
MOVI STUDY
Scientific Title
A Randomized Controlled Trial compares the efficacy of Moviprep vs Muben on the bowel preparation of the patients who undergo colorectal endoscopic submucosal dissection
Scientific Title:Acronym
MOVI STUDY
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of Moviprep (low-volume colonoscopy prep) and Muben (standard-volume) on the bowel preparation for the patients undergo colorectal endoscopic submucosal dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Preparation time
Key secondary outcomes
Boston Bowel Preparation Scale score, acceptability, taste, frequencies of stool, total volume of the prep, complication rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Moviprep 1.5L ~ 2L
Interventions/Control_2
Muben 3L ~ 4L
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 who underwent colorectal endoscopic submucosal dissection (ESD) at National Cancer Center Hospital.
1. Indication for colorectal ESD
2. Irrespective of number of the lesion
3. Age from 20 years old to 75 years old
4. Performance status 0, 1, 2
5. Patients who has written informed consent for this study
Key exclusion criteria
1. Patients having risk of perforation, obstruction and suspicious of ileum.
2. Toxic megacolon
3. Allergy for Moviprep and Muben
4. Dehydration
5. Mental disease
6. Without written informed consent
7. Angina pectoris and/or past history of myocardial infarction within 6 months.
8. Active inflammatory bowel diseases
9. Past history of convulsive attack
10. Serum creatinine level ≥1.3 mg/dL
11. Others (depends on the chief physician)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Matsuda |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
+81-3-3542-2511
tamatsud@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Yamada |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
+81-3-3542-2511
Homepage URL
masyamad@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals 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
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2017 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017061
