UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026944 |
|---|---|
| Receipt number | R000030891 |
| Scientific Title | Randomized Comparative Study on the Clinical Usefulness of PICOPREP and MOVIPREP |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2017/10/11 09:26:50 |
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Basic information
Public title
Randomized Comparative Study on the Clinical Usefulness of PICOPREP and MOVIPREP
Acronym
Comparative examination of laxatives
Scientific Title
Randomized Comparative Study on the Clinical Usefulness of PICOPREP and MOVIPREP
Scientific Title:Acronym
Comparative examination of laxatives
Region
| Japan |
Condition
Condition
Colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of efficacy and safety about two laxatives
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Evaluation of intestinal cleasing degree using
Boston Bowel Preparation Scale (BBPS)at colonoscopy
Key secondary outcomes
adverse events after taking laxatives
Easiness to take laxative
Sleeping time on the day before colonoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The patient drinks 1000 to 2000 ml of MOVIPREP and 500 to 1000 ml of water on the day of colonoscopy.
Interventions/Control_2
The patient takes 150 ml of PICOPREP and 750 to 1250 ml of water or clear beverages on the day before colonoscopy.
The patient takes 150 ml of PICOPREP and 750 to 1250 ml of water or clear beverages on the day of colonoscopy.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who wanted colonoscopy and agreed to this research
Key exclusion criteria
Person who took laxative in hospital
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Suzuki |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1 Chigasaki Chuo Tsuzuki-ku Yokohama-city Kanagawa Japan
TEL
045-949-7000
kenichi.suzuki.19860617@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Suzuki |
Organization
Kudo Gastroenterology Clinic
Division name
Gastroenterology
Zip code
Address
2F Akita Castle Hotel 1-3-5 Nakadouri Akita-city Akita Japan
TEL
018-825-9100
Homepage URL
kenichi.suzuki.19860617@gmail.com
Sponsor or person
Institute
Kudo Gastroenterology Clinic
Institute
Department
Personal name
Funding Source
Organization
Kudo Gastroenterology Clinic
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2017 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030891
