UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017122 |
|---|---|
| Receipt number | R000018900 |
| Scientific Title | Evaluation of Medication adherence and cleaning effect of Moviprep for preparation of colonoscopy |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/10/19 13:40:26 |
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Basic information
Public title
Evaluation of Medication adherence and cleaning effect of Moviprep for preparation of colonoscopy
Acronym
Evaluation of utility of new laxative Moviprep.
Scientific Title
Evaluation of Medication adherence and cleaning effect of Moviprep for preparation of colonoscopy
Scientific Title:Acronym
Evaluation of utility of new laxative Moviprep.
Region
| Japan |
Condition
Condition
Patients scheduled for colonoscopy
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical utility (colon cleansing) and the tolerability of Moviprep compared with Niflec.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical utility (colon cleansing) and the tolerability.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Moviprep + Modified Brown Method
Interventions/Control_2
Moviprep + Laxative
Interventions/Control_3
Niflec + Modified Brown Method
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who planned a colonoscopy.
2) Patients 20 years of age or older.
3) Patients who agreed to participate in this study.
Key exclusion criteria
1) Patients who has obstruction and/or suspicious obstruction of gastrointestinal tract.
2) Patients who has intestinal perforation.
3) Patients who has delayed exhaust in stomach.
4) Patients with toxic megacolon.
5) Patients after abdominal operation.
6) Patients with a history of allergy this drug.
7) Patients who have no stool until the inspection day.
8) Patients who are not suitable for attending the study.
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
734-8551
Address
1-2-3, kasumi, minamiku, hiroshima
TEL
082-257-5538
colon@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
734-8551
Address
1-2-3, kasumi, minamiku, hiroshima
TEL
082-257-5939
Homepage URL
oka4683@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals Co.,Inc.
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
Hiroshima University hospital IRB
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
Tel
082-257-5596
hugcp@hiroshima-u.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
県立広島病院（広島県）、広島市立広島市民病院（広島県）、広島市立安佐市民病院（広島県）、尾道総合病院（広島県）、中国労災病院（広島県）、マツダ病院（広島県）、三次地区医療センター（広島県）、河村内科消化器クリニック（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
360
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
| 2015 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018900
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