UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002562 |
|---|---|
| Receipt number | R000002342 |
| Scientific Title | Reviewing of the bowel preparation for Colon Capsule Endoscopy |
| Date of disclosure of the study information | 2009/10/13 |
| Last modified on | 2010/05/02 08:34:38 |
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Basic information
Public title
Reviewing of the bowel preparation for Colon Capsule Endoscopy
Acronym
Colon Capsule Preparation Study
Scientific Title
Reviewing of the bowel preparation for Colon Capsule Endoscopy
Scientific Title:Acronym
Colon Capsule Preparation Study
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 colon preparation method can obtain the same good cleansing level and a 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
Colon cleansing level and anus excretion rate
Key secondary outcomes
Transit time in total digestive tract
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
A group
Day before test: No administration of Polyethylene glycol(PEG).
Test day: Administer PEG (2L).
After completion of preparation, Colon Capsule procedure starts.
Interventions/Control_2
B group
Day before test: Administer Polyethylene glycol (PEG) (2L) in the evening.
Test day: Administer PEG (1L).
After completion of preparation, Colon Capsule procedure starts.
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
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients who have planned to undergo Colon Capsule procedure, or asymptomatic healthy volunteers
- Obtaining informed consent
Key exclusion criteria
1) Subjects who have a swallowing disorder
2) Subject who has 2 < bowel movements per week.
3) Subjects who take nonsteroidal anti-inflammatory drug for long period (more than 6 months)
4) Subjects who take anti-thrombotic medicine or anticoagulant
5) Subjects who take iron pills
6) Subjects who take morphine hydrochloride
7) Subjects who take tranquilizers
8) Subjects who have a history of allergic reaction to the following medicines (1 - 4) used in this study. These medicines are used normally in the clinical situations in Japan.
1. Magnesium citrate solution, Polyethylene glycol 2. Mosapride citrate 3. Dimethicone, Pronase, Sodium bicarbonate 4. Bisacodyl 5.Glycerin 6.sennoside
9) Subjects who are pregnant
10) Subjects who are scheduled to have MRI examination within the next 2 weeks
11) Subjects who have a cardiac pacemaker implanted or other medical electronic devices applied in the body
12) Subjects who have a history of digestive tract anastomosis
13) Subjects who have a history of abdominal operation
14) Subjects who have a suspected symptom or who have a history of intestinal obstruction or intestinal stenosis
15) Subjects who have a small intestine tumor or who have a suspected symptom of it
16) Subjects who have an advanced large intestine cancer or who have a suspected symptom of it
17) Subjects who have a diabetes
18) Subjects who have a diverticulum in digestive tract
19) Subjects who have a history of radiotherapy
20) Subjects who have an accompanying cancerous peritonitis
21) Subjects who have a renal dysfunction
22) Subjects who have a heart disease
23) Subjects who have a clone disease or ulcerative colitis
24) Subjects who have a familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
25) Subjects who had a incomplete total colonoscopy before
26) Other cases where doctor considers it inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1 Tsukiji Chuo-ku Tokyo, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Kakugawa |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
TEL
03-3542-2511
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jikei University School of Medicine, Nagoya University, Osaka City University, Osaka Medical College, Hiroshima 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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 13 | 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
| 2009 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 29 | Day |
Last modified on
| 2010 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002342
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