UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024073 |
|---|---|
| Receipt number | R000027705 |
| Scientific Title | Evaluation of a new preparation regimen in colon capsule endoscopy |
| Date of disclosure of the study information | 2016/09/20 |
| Last modified on | 2019/05/27 23:12:56 |
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Basic information
Public title
Evaluation of a new preparation regimen in colon capsule endoscopy
Acronym
A new preparation regimen in colon capsule endoscopy
Scientific Title
Evaluation of a new preparation regimen in colon capsule endoscopy
Scientific Title:Acronym
A new preparation regimen in colon capsule endoscopy
Region
| Japan |
Condition
Condition
Asymptomatic volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of a new preparation regimen in colon capsule endosocpy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
capsule excretion rate
Key secondary outcomes
feelings during and after prepation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Standard preparation regimen in Europe
Interventions/Control_2
New preparation regimen
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Volunteers who are able to write a consent form
Key exclusion criteria
1. Subjects who have dysphagia or aspiration pneumonia
2. Subjects who have history of surgery in gastrointestinal tract
3. Subjects who may have gastrointestinal obstruction
4. Subjects who have toxic megacolon
5. Subjects who have hypertension or renal failure
6. Subjects who have congestive heart failure or unstable angina
7. Subjects who have long QT syndrome or serious arrythmia
8. Subjects who have ascites
9. Subjects who have electrolyte imbalance
10. Subjects who have delayed gastric emptying
11. Subjects who have pacemaker or implantable cardioverter-defibrillator
12. Subjects who have allergy for drugs and foods used in the study
13. Subjects who are pregnant and who are breast-feeding
14. Subjects who are not suitable for the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
0272208137
shikokuri@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
0272208137
Homepage URL
shikokuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
Department of Gastroenterology and Hepatology
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
Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8137
shikokuri@gunma-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
1
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2016 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027705
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
