UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015724 |
|---|---|
| Receipt number | R000018277 |
| Scientific Title | Examination of the safety of Moviprep in elderly people and dialysis patients |
| Date of disclosure of the study information | 2014/11/20 |
| Last modified on | 2015/04/07 19:12:08 |
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Basic information
Public title
Examination of the safety of Moviprep in elderly people and dialysis patients
Acronym
Examination of the safety of Moviprep in elderly people and dialysis patients
Scientific Title
Examination of the safety of Moviprep in elderly people and dialysis patients
Scientific Title:Acronym
Examination of the safety of Moviprep in elderly people and dialysis patients
Region
| Japan |
Condition
Condition
The patient who have colonoscopy
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this examination is to confirm a safety of Moviprep in dialysis patients and elderly people .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Influences of Moviprep to blood test data, vital sign, weight etc.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Moviprep
(It is Niflec administration when undergoing the 2nd colonoscopy)
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are tolerated to colonoscopy and Moviprep preparation.
Patients who has informed consents.
Key exclusion criteria
Patients of contraindications to Niflec or Moviprep
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gentaro Aridome |
Organization
Moji Medical center
Division name
Internal medicine
Zip code
Address
3-1, Higashi-Minatomachi, Moji-ku, Kitakyushu-shi, Fukuoka-ken
TEL
093-331-3461
biggen@msj.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyoshi Ogino |
Organization
University of Occupational and Environmental Health
Division name
Third Department of Internal Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka
TEL
093-603-1611
Homepage URL
n-ogino@med.uoeh-u.ac.jp
Sponsor or person
Institute
Moji Medical center
Institute
Department
Personal name
Funding Source
Organization
Moji Medical center
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 11 | Month | 20 | 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
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 14 | 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
| 2014 | Year | 11 | Month | 19 | Day |
Last modified on
| 2015 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
