UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004649 |
|---|---|
| Receipt number | R000005540 |
| Scientific Title | Reviewing of the bowel preparation for Colon Capsule Endoscopy (Further Work) |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2012/01/30 10:07:04 |
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Basic information
Public title
Reviewing of the bowel preparation for Colon Capsule Endoscopy (Further Work)
Acronym
C1 Prep Add
Scientific Title
Reviewing of the bowel preparation for Colon Capsule Endoscopy (Further Work)
Scientific Title:Acronym
C1 Prep Add
Region
| Japan |
Condition
Condition
Subjects who undergo Colon Capsule Endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify whether Japanese specific 1- day colon preparation method can obtain as high anus excretion rate as the oversea methods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Anus excretion rate
Key secondary outcomes
Colon cleansing level
Base
Study type
Interventional
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Conduct a modified version of the Japan original 1 day bowel preparation method (Moisture load (Laxative): 3.8L, administration of laxative only on the test day, no breakfast on the test day only). Modifications include 1. 5 walking sessions between 5-10 minutes during procedure, 2. Ingest Capsule 2 hour earlier (the time changed from 12:00 PM to 10:00 AM, 3. Reduce an amount of intake of Dimethicone, and 4. Obligatory administration of suppository, 5. In case of unexcreation of capsule, additionally booster 3, 4 are prescribed with light meal.
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are between 40 - 79 years of age and have planned to undergo Colonoscopy.
Key exclusion criteria
1) Subjects who have a swallowing disorder
2) Subjects who have a history of allergic reaction to the following medicines (1 - 6) used in this study. These medicines are used normally in the clinical situations in Japan.
1. Polyethylene glycol 2. Magnesium citrate solution 3. Mosapride citrate 4. Dimethicone, Pronase, Sodium bicarbonate 5. Bisacodyl 6. Glycelin
3) Subjects who are pregnant
4) Subjects who have a cardiac pacemaker implanted or other medical electronic devices applied in the body
5) Subjects who have a suspected symptom or who have a history of intestinal obstruction or intestinal stenosis
6) Subjects who have a history of radiotherapy
7) Subjects who have Crohn's disease
or ulcerative colitis
8) Other cases where doctors consider it inappropriate
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Saito MD, PhD |
Organization
National Cancer Center Hospital
Division name
Division of Endoscopy
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Kakugawa MD |
Organization
National Cancer Center, Research Center for Cancer Prevention and Screening
Division name
Screening Technology and Development Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jikei University
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
国立がん研究センター(東京都)、東京慈恵会医科大学(東京都)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2012 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
