UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011035 |
|---|---|
| Receipt number | R000012745 |
| Scientific Title | A study on bowel preparation using low-volume polyethylene glycol (Moviprep) |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2015/12/26 11:02:08 |
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Basic information
Public title
A study on bowel preparation using low-volume polyethylene glycol (Moviprep)
Acronym
A study on bowel preparation using low-volume polyethylene glycol (Moviprep)
Scientific Title
A study on bowel preparation using low-volume polyethylene glycol (Moviprep)
Scientific Title:Acronym
A study on bowel preparation using low-volume polyethylene glycol (Moviprep)
Region
| Japan |
Condition
Condition
Colonoscopy Preparation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Randomized Trial of Niflec and Magcorol and Moviprep for Colonoscopy Preparation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tolerability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Colonoscopy preparation using Niflec
Interventions/Control_2
Colonoscopy preparation using Magcorol P
Interventions/Control_3
Colonoscopy preparation using Moviprep
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 in need of colonoscopy
2) Patients who agreed to participate in this research
Key exclusion criteria
Patients with contraindications of this study drugs
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1, Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Yuki |
Organization
Shimane Medical University Hospital
Division name
Division of Gastrointestinal Endoscopy
Zip code
Address
89-1, Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2190
Homepage URL
yukitaka@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Shimane University School of Medicine
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
| 2013 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 08 | 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
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012745
